FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM
Report
- Report Number
- 3002808486-2017-00002
- Event Type
- Malfunction
- Date Received
- January 2, 2017
- Date of Event
- December 6, 2016
- Report Date
- December 7, 2016
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- KRD
- UDI-DI
- 00827002200265
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). SIMILAR TO DEVICE WITH 510(K) K063619. INVESTIGATION IS STILL IN PROGRESS
(B)(4). SIMILAR TO DEVICE WITH 510(K) K063619. SUMMARY OF INVESTIGATIONAL FINDINGS UPDATED 01MAR2017: THE INVESTIGATION OF THIS COMPLAINT WAS GATHERED WITH THE EVENT REPORTED IN (B)(4). THE PRODUCT EVALUATION REVEALED THIS FAILURE TO BE RELATED TO THE LOADING PROCEDURE OF THE COIL TO THE DELIVERY WIRE AND THE WORK ORDER FOR THE COMPLAINT DEVICE APPEARS TO BE COMPLETE AND CORRECT, WITH NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
(B)(4). PMA 510(K): SIMILAR TO DEVICE WITH 510(K) K063619. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THE DESCRIPTION OF EVENT AND VISUAL INSPECTION, IT IS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF WHY THE COIL WOULD NOT DETACH FROM THE DELIVERY WIRE. VISUAL INSPECTION SHOWED KINK ON THE STRAIGHTENING MANDRIL AND WHEN MANDRIL DOES NOT REACH THE TIP OF THE COIL, THE COIL COILS UP AND PREVENTS THE ADVANCEMENT. AND IT WAS NOT POSSIBLE TO DETERMINE WHY THE THREAD OF THE COIL WAS SPOILED AND MIXED INTO THE THREAD OF THE DELIVERY WIRE, WHICH MAKES IT NOT POSSIBLE TO DETACH THE COIL, BUT PLAUSIBLE IT OCCURRED DUE TO NOT TURNING THE PIN VISE COUNTERCLOCKWISE TO DETACH THE DELIVERY WIRE FROM THE COIL AND/OR BECAUSE THE PIN VISE WAS NOT PROPERLY LOCKED TO THE PROXIMAL END OF THE DELIVERY WIRE AS SPECIFIED IN THE IFU. NO EVIDENCE TO SUGGEST PRODUCT WAS NOT MANUFACTURED TO SPECIFICATIONS COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: IMWCE-3-PDA3/(B)(4)(MFR REPORT#: 3002808486-2017-00001) + TDS-110-PDA/ (B)(4)(MFR REPORT#: 3002808486-2017-00002) WERE USED, BUT THE COIL WOULD NOT BE DETACHED FROM THE DELIVERY WIRE. THEN, THESE DEVICES WERE REPLACED WITH OTHER COIL + TDS TO COMPLETE THE PROCEDURE. PATIENT OUTCOME: THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: IMWCE-3-PDA3/(B)(3)(MFR REPORT#: 3002808486-2017-00001) + TDS-110-PDA/ (B)(4) (MFR REPORT#: 3002808486-2017-00002) WERE USED, BUT THE COIL WOULD NOT BE DETACHED FROM THE DELIVERY WIRE. THEN, THESE DEVICES WERE REPLACED WITH OTHER COIL + TDS TO COMPLETE THE PROCEDURE. PATIENT OUTCOME: THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: (B)(4) (MFR REPORT#: 3002808486-2017-00001) + (B)(4) (MFR REPORT#: 3002808486-2017-00002) WERE USED, BUT THE COIL WOULD NOT BE DETACHED FROM THE DELIVERY WIRE. THEN, THESE DEVICES WERE REPLACED WITH OTHER COIL + TDS TO COMPLETE THE PROCEDURE. PATIENT OUTCOME: THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144 | FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM | KRD DEVICE, EMBOLIZATION, VASCULAR | KRD | WILLIAM COOK EUROPE | 00827002200265 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |