Device product
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC 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-0232-2022
Product summary
- Event
- Event 88796
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1245 units
- Official record key
device-enforcement:Z-0232-2022
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: 13F19K0369 13F20A0323 13F20B0139 13F20C0594 13F20F0083 13F20F0230 13F20F0577 13F20H0756 13F20K0849 13F20L0283 13F20M0182 13F21A0498 13F21B0158 13F21C0747 13F21E0555
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.