Device product
0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE EO
Z-1792-2020
Product summary
- Event
- Event 85398
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1190 units
- Official record key
device-enforcement:Z-1792-2020
Official wording
Reason: The stiffness of the soft end of the guidewire caused tissue perforation.
Code information: Guidewire Model 114135150; LOT numbers: 11248718, 11251204, 11260495. 11268741, 11242667, 11241250 and 11239540
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.