FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM
Report
- Report Number
- 3002808486-2018-01075
- Event Type
- Malfunction
- Date Received
- September 14, 2018
- Date of Event
- August 23, 2018
- Report Date
- February 4, 2019
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- KRD
- UDI-DI
- 00827002200265
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) SIMILAR TO DEVICE UNDER PMA/510(K) K150964. (B)(4). INVESTIGATION IS STILL IN PROGRESS.
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI), 400 DANIELS WAY, BLOOMINGTON, IN 47404, REGISTRATION NO.: 3005580113. SUMMARY OF INVESTIGATIONAL FINDINGS: THE INVESTIGATION IS BASED ON EVENT DESCRIPTION AND THE RETURNED IMWCE AND TDS. THE PRODUCTS WERE RETURNED WITH EVIDENCE OF BIOLOGICAL MATTER ON BOTH. THE IMWCE HAD A MINOR BENT ON THE THREAD. THE IMWCE WAS DETACHED AND ATTACHED TO THE TDS SEVERAL TIMES WITHOUT ANY DIFFICULTY. IT WAS NOT POSSIBLE TO MOVE THE STRAIGHTENING MANDRIL ON THE TDS, PROPERLY DUE TO SOLIDIFIED BLOOD, CONTRAST MEDIUM OR OTHER, BUT IT IS ASSUMED THAT THE STRAIGHTENING MANDRIL PERFORMED AS INTENDED DURING THE PROCEDURE, AS THE COIL WAS PLACED IN THE COIL LOADING CARTRIDGE UPON RETURNING. IT HAS NOT BEEN POSSIBLE TO VERIFY THE FAILURE IN THE LABORATORY, WHY AN EXACT ROOT CAUSE CANNOT BE DETERMINED, BUT E.G. INSUFFICIENT TURNS COUNTERCLOCKWISE, EXCESSIVE TIGHTENING OF IMWCE AND TDS WHEN LOADED, SOLIDIFIED BLOOD OR CONTRAST MEDIUM ARE POSSIBLE CAUSES. NO ADVERSE EFFECTS TO THE PATIENT REPORTED. NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE DEVICE WAS USED FOR EMBOLIZATION TO TREAT PDA BY FEMORAL APPROACH. HOWEVER, BECAUSE THE COIL WOULD NOT BE DETACHED FROM TDS INSIDE THE PATIENT BODY, THESE WERE REPLACED WITH OTHER DEVICES. THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT DEVICES. PATIENT OUTCOME: THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 718255 | FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM | KRD DEVICE, EMBOLIZATION, VASCULAR | KRD | WILLIAM COOK EUROPE | E3737668 | 00827002200265 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |