PENUMBRA SMART COIL
Report
- Report Number
- 3005168196-2021-02390
- 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
- 00814548015385
- 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 CONFIRMED THAT THE EMBOLIZATION COIL WAS INTACT WITH THE PUSHER ASSEMBLY. FURTHER EVALUATION REVEALED THAT THE PULL WIRE WAS FRACTURED ON THE PROXIMAL END OF THE PUSHER ASSEMBLY, AND THE DISTAL END WAS IN ITS INITIAL POSITION WITHIN THE PUSHER ASSEMBLY DDT. THIS INDICATES THAT THE PULL WIRE BECAME FRACTURED WITHIN THE PUSHER ASSEMBLY. THIS DAMAGE LIKELY CONTRIBUTED TO THE INABILITY TO DETACH THE EMBOLIZATION COIL DURING THE PROCEDURE AND THE ROOT CAUSE COULD NOT BE DETERMINED. FURTHER EVALUATION REVEALED PUSHER ASSEMBLY KINKS. THIS DAMAGE WAS LIKELY INCIDENTAL TO THE REPORTED COMPLAINT. 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:3005168196-2021-02390. 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. 3005168196-2021-02391, 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 |
|---|---|---|---|---|---|---|---|
| 1598476 | PENUMBRA SMART COIL | HCG, KRD | HCG | PENUMBRA, INC. | 400SMTXSFT0406 | F105948 | 00814548015385 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |