PENUMBRA SMART COIL
Report
- Report Number
- 3005168196-2021-02391
- Event Type
- Malfunction
- Date Received
- October 26, 2021
- Date of Event
- September 28, 2021
- Report Date
- February 16, 2022
- Manufacturer
- PENUMBRA, INC.
- Product Code
- HCG
- UDI-DI
- 00814548015811
- PMA / PMN Number
- K160832
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
EVALUATION OF THE RETURNED SMART COIL REVEALED THAT THE PET LOCK WAS INTACT ON THE PROXIMAL END OF THE PUSHER ASSEMBLY, KINKS WERE PRESENT NEAR THE PUSHER ASSEMBLY MID-JOINT, THE MID-JOINT WAS RETRACTED THROUGH THE INTRODUCER SHEATH FRICTION LOCK, AND THE EMBOLIZATION COIL WAS UNDAMAGED AND INTACT WITH THE PUSHER ASSEMBLY. WHILE ATTEMPTING TO ADVANCE THE SMART COIL FROM ITS RETURNED POSITION WITHIN THE INTRODUCER SHEATH, RESISTANCE WAS EXPERIENCED DUE TO THE PUSHER ASSEMBLY KINKS, AND THE COIL COULD NOT ADVANCE ANY FURTHER. BASED ON THE DAMAGE OBSERVED ON THE DEVICE, THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED. PLEASE NOTE THAT THE FOLLOWING SECTION IS BEING UPDATED BASED ON ADDITIONAL INFORMATION PROVIDED BY A PENUMBRA SALES REPRESENTATIVE ON 27-JAN-2022: 1. SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM PLEASE NOTE THAT THE FOLLOWING SECTIONS WERE INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND ARE BEING CORRECTED ON THIS FOLLOW-UP #01 MFR REPORT. 1. SECTION D. BOX 4. LOT NUMBER, CATALOG NUMBER, EXPIRATION DATE, UNIQUE IDENTIFIER. 2. SECTION H. BOX 4. DEVICE MANUFACTURE DATE. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1. 3005168196-2021-02388 2. 3005168196-2021-02389 3. 3005168196-2021-02390 4. 3005168196-2021-02392 5. 3005168196-2021-02393 6. 3005168196-2021-02394 7. 3005168196-2021-02396 8. 3005168196-2021-02398 9. 3005168196-2021-02399 10. 3005168196-2021-02401 11. 3005168196-2021-02402 H3 OTHER TEXT : PLACEHOLDER.
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, A 5F DIAGNOSTIC CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH FIVE OTHER SMART COILS. IT WAS REPORTED THAT ATTEMPTS WERE MADE TO DETACH THE SMART COILS WITH THREE DIFFERENT HANDLES. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS.
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE), A NON-PENUMBRA MICROCATHETER, A 5F DIAGNOSTIC CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH EIGHT OTHER SMART COILS. IT WAS REPORTED THAT ATTEMPTS WERE MADE TO DETACH THE SMART COILS WITH THREE DIFFERENT HANDLES. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1598470 | PENUMBRA SMART COIL | HCG, KRD | HCG | PENUMBRA, INC. | 400SMTHXSFT0406 | F104973 | 00814548015811 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |