Device product
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthetic dialysis grafts
Z-0231-2022
Product summary
- Event
- Event 88796
- Status
- Terminated
- Classification
- Class I
- Quantity
- 447 units
- Official record key
device-enforcement:Z-0231-2022
Official wording
Reason: 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.
Code information: Lot Number: 13F19K0564 13F20C0094 13F20G0284 13F20L0282 13F21A0497 13F21A0718 13X21E0008 13F21F1187
Distribution pattern: Worldwide distribution: US (Nationwide) and OUS (Foreign) to countries of: BE CA CL CZ DE ES FR IL IT KR PH SA TR TW UK
Derived failure modes
-
Unknown
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.