Device product
Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.
Z-3012-2020
Product summary
- Event
- Event 86328
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 units
- Official record key
device-enforcement:Z-3012-2020
Official wording
Reason: Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Packages labeled Model IBI-87002, batch 7397307 incorrectly contained Model IBI-81104, batch 7397352.If physicians fail to observe the catheter difference, the intracardiac electrograms will not be representative of the desired signals, could result in procedure delay
Code information: GTIN: 05414734309936, Lot: 7397307
Distribution pattern: Worldwide distribution - U.S. Nationwide distribution including the states of MO, IN, WI, TX, AZ, MI, VA, KY and the country of Japan.
Derived failure modes
-
Unknown
Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Packages labeled Model IBI-87002, batch 7397307 incorrectly contained Model IBI-81104, batch 7397352.If physicians fail to observe the catheter difference, the intracardiac electrograms will not be representative of the desired signals, could result in procedure delay