Device product
0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO
Z-1791-2020
Product summary
- Event
- Event 85398
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1690 units
- Official record key
device-enforcement:Z-1791-2020
Official wording
Reason: The stiffness of the soft end of the guidewire caused tissue perforation.
Code information: Guidewire Model 114135080; LOT numbers: 11235895, 11234476, 11237014, and 11240602.
Distribution pattern: No US consignees. OUS - Sweden, Norway, Denmark, Greece, Slovenia, Turkey, Hong Kong, England
Derived failure modes
-
Unknown
The stiffness of the soft end of the guidewire caused tissue perforation.