FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM
Report
- Report Number
- 3002808486-2018-01068
- Event Type
- Malfunction
- Date Received
- September 12, 2018
- Date of Event
- August 24, 2018
- Report Date
- February 21, 2019
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- 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 510(K) K150964. (B)(4). INVESTIGATION IS STILL IN PROGRESS. 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.
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# PR238510. G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. SUMMARY OF INVESTIGATIONAL FINDINGS: CONCERNING COIL COULD NOT BE PROPERLY CONNECTED TO TDS AND DETACHED INSIDE A CATHETER. THE INVESTIGATION IS BASED ON EVENT DESCRIPTION AND THE RETURNED TDS. THE COIL IN THE PROCEDURE WAS NOT RETURNED (PR238509). THE RETURNED TDS WAS RETURNED WITH A SMALL BENT 25 CM FROM DISTAL END. IT WAS IMPOSSIBLE TO MOVE THE STRAIGHTENING MANDRIL, PROPERLY DUE TO HARDEN CONTRAST MEDIUM. AS A PART OF THE PRODUCT EVALUATION, A COIL WAS ATTACHED AND DETACHED WITHOUT PROBLEMS. NOT ENOUGH INFORMATION IS PROVIDED TO CONCLUDE ON A MOST LIKELY ROOT CAUSE, BUT E.G. INCOMPLETE LOADING OR WIRE ROTATED COUNTERCLOCKWISE DURING INSERTION ARE POSSIBLE CAUSES. NO ADVERSE EFFECTS TO THE PATIENT REPORTED. NO EVIDENCE WAS FOUND SUGGESTING 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.
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# PR238510. 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 THE EVENT DESCRIPTION AND PRODUCT EVALUATION OF THE RETURNED COIL (PR238509) AND TDS (PR238510). THE CATHETER USED IN THE PROCEDURE IS UNKNOWN. THE RETURNED TDS WAS RETURNED WITH A SMALL BENT 25CM FROM DISTAL END. IT WAS IMPOSSIBLE TO MOVE THE STRAIGHTENING MANDRIL PROPERLY DUE TO HARDEN CONTRAST MEDIUM. THE RETURNED COIL COULD BE DETACHED COMPLETELY, BUT WITH A BIT OF RESISTANCE. A TEST COIL WAS ATTACHED AND DETACHED WITHOUT PROBLEMS. MEASURING AND VISUAL INSPECTION OF THE THREAD COMPLIES WITH SPECIFICATIONS. IT IS NOT POSSIBLE TO CONCLUDE AN EXACT ROOT CAUSE, BUT THE MINOR COMPRESSION IN THE THREAD OF THE COIL MAY HAVE CAUSED THE TROUBLED AND INCOMPLETE LOADING, AND A SLIGHT, UNINTENDED COUNTERCLOCKWISE WIRE ROTATION DURING INSERTION MAY HAVE CAUSED THE IMPROPERLY LOADED COIL TO PREMATURELY DEPLOY IN THE UNKNOWN CATHETER. NO EVIDENCE WAS FOUND SUGGESTING 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.
THE DEVICE WAS USED FOR EMBOLIZATION TO TREAT PDA BY FEMORAL APPROACH. THE COIL COULD NOT BE CONNECTED WITH THE TDS PROPERLY, SO THE COIL BECAME DETACHED FROM THE TDS INSIDE A CATHETER. SINCE THE PHYSICIAN THOUGHT IT WOULD BE RISKY TO CONTINUE TO USE THE DEVICES, HE REPLACED THEM WITH NEW ONES AND COMPLETED THE PROCEDURE. 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.
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 |
|---|---|---|---|---|---|---|---|
| 709765 | FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE | E3751142 | 00827002200265 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |