FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM
Report
- Report Number
- 3002808486-2021-01143
- Event Type
- Injury
- Date Received
- April 23, 2021
- Report Date
- December 19, 2022
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- KRD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
MANUFACTURERS REF# (B)(4). AFTER INVESTIGATION THE EVENT FOR THIS PR IS NO LONGER REPORTABLE. SUMMARY OF INVESTIGATIONAL FINDINGS: REPORTEDLY ¿TWO FLIPPER COILS WERE NOT POSSIBLE TO DETACH FROM THE TDS SYSTEM. FIRST COIL WAS NOT POSSIBLE TO DETACH (THEY FLUSHED THE COIL), THEY CHANGE THEM INTO A NEW/ SECOND COIL. THIS SECOND COIL ALSO NOT POSSIBLE TO DETACH FROM THE SYSTEM BECAUSE THE COIL AND THE TDS CATHETER GET CAUGHT AND TWISTED, SLIPS IN AORTA AND HERE THEY DETACH WITH DIFFICULTY THE COIL FROM TDS. THE COILS DISSOCIATED IN FREE AORTA BUT THEY CATCH THEM WITH A SNARE.¿ ONE TDS DELIVERY WIRE AND ONE PDA COIL IN THE LOADING CARTRIDGE WERE RETURNED IN ONE POUCH. ANOTHER TDS AND ANOTHER COIL WERE RETURNED IN SEPARATE POUCHES. IN THE TDS RETURNED WITH THE COIL THE STRAIGHTENING MANDRIL INSIDE WAS STICKING AND COULD NOT BE MOVED. NO NONCONFORMANCES WERE NOTED IN THE MOST DISTAL PART OF THE THREAD, BUT THE PROXIMAL PART WAS ELONGATED. THE COIL INSIDE THE CARTRIDGE WAS FOUND ACCORDING TO SPECIFICATIONS AND COULD EASILY BE LOADED TO THE DISTAL PART OF THE TDS THREAD BY CLOCKWISE ROTATING THE CARTRIDGE. FOLLOWING DETACHMENT OF THE COIL WAS PERFORMED WITHOUT DIFFICULTIES BY COUNTERCLOCKWISE ROTATION OF THE PIN VISE. A TDS DELIVERY WIRE AND A SEPARATED PDA COIL WERE RETURNED. ON THE TDS THE THREAD HAD ELONGATED AND THE STRAIGHTENING MANDRIL INSIDE COULD NOT BE MOVED. A SMALL THREAD-LIKE PIECE WAS FASTENED TO THE TDS 19MM FROM THE DISTAL TIP. HOWEVER, UNFORTUNATELY THIS PIECE WAS LOST DURING THE INVESTIGATION BEFORE BEING IDENTIFIED. ON THE COIL THE MOST DISTAL PART OF THE THREAD WAS MISSING AS IF CUT, THE MOST DISTAL SEVEN WINDINGS WERE ACCORDING TO SPECIFICATIONS, AND THE NEXT SIX WINDINGS WERE SEVERELY ELONGATED. IMMEDIATELY, IT CANNOT BE DETERMINED EXACTLY HOW OR WHEN IN TIME THE THREAD HAD SEPARATED, BUT A DETAILED SCANNING ELECTRON MICROSCOPY ANALYSIS DID NOT REVEAL ANY SIGN OF MATERIAL NON-CONFORMANCE. NO IMAGING WAS PROVIDED, NOR COULD ADDITIONAL INFORMATION BE OBTAINED AND BASED ON THE INVESTIGATION FINDINGS IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE CAUSED THE DIFFICULTIES ENCOUNTERED WHEN ATTEMPTING TO DETACH THE COILS. HOWEVER, THE INSTRUCTIONS FOR USE CAUTION THAT IN CASE OF DIFFICULTIES WITH DETACHING THE COIL, THE GUIDING CATHETER AND THE DELIVERY WIRE MUST BE REMOVED WITH THE COIL SIMULTANEOUSLY AND THE WHOLE SYSTEM MUST BE REPLACED. THE IFU ALS CAUTION THAT THE STRAIGHTENING MANDRIL MUST BE AT THE TIP OF THE COIL DURING THE PROCEDURE, OTHERWISE THE COIL MAY START COILING UP INSIDE THE CATHETER, THUS COMPLICATING THE COIL DETACHMENT. HOWEVER, THERE IS NO INFORMATION CONCERNING THE CATHETER USED, BUT THE IFU RECOMMEND THE USE OF A 5FR, NON-TAPERED, END HOLE ONLY, MULTIPURPOSE HEART CATHETER WITH MIN. LUMEN .041 INCHES TO OBTAIN STABILITY DURING COIL INTRODUCTION. IT WAS ASSESSED THAT BECAUSE NO NON-CONFORMANCES WERE DETECTED, THERE IS EVIDENCE THAT THE DHR WAS FULLY EXECUTED. IT IS THEREFORE CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR 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.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
MANUFACTURER REF# (B)(4). SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K150964. SUMMARY OF INVESTIGATIONAL FINDINGS: REPORTEDLY TWO FLIPPER COILS WERE NOT POSSIBLE TO DETACH FROM THE TDS SYSTEM. FIRST COIL WAS NOT POSSIBLE TO DETACH (THEY FLUSHED THE COIL), THEY CHANGE THEM INTO A NEW/ SECOND COIL. THIS SECOND COIL ALSO NOT POSSIBLE TO DETACH FROM THE SYSTEM BECAUSE THE COIL AND THE TDS CATHETER GET CAUGHT AND TWISTED, SLIPS IN AORTA AND HERE THEY DETACH WITH DIFFICULTY THE COIL FROM TDS. THE COILS DISSOCIATED IN FREE AORTA BUT THEY CATCH THEM WITH A SNARE. ONE TDS DELIVERY WIRE AND ONE PDA COIL IN THE LOADING CARTRIDGE WERE RETURNED IN ONE POUCH. ANOTHER TDS AND ANOTHER COIL WERE RETURNED IN SEPARATE POUCHES. IN THE TDS RETURNED WITH THE COIL THE STRAIGHTENING MANDRIL INSIDE WAS STICKING AND COULD NOT BE MOVED. NO NONCONFORMANCES WERE NOTED IN THE MOST DISTAL PART OF THE THREAD, BUT THE PROXIMAL PART WAS ELONGATED. THE COIL INSIDE THE CARTRIDGE WAS FOUND ACCORDING TO SPECIFICATIONS AND COULD EASILY BE LOADED TO THE DISTAL PART OF THE TDS THREAD BY CLOCKWISE ROTATING THE CARTRIDGE. FOLLOWING DETACHMENT OF THE COIL WAS PERFORMED WITHOUT DIFFICULTIES BY COUNTERCLOCKWISE ROTATION OF THE PIN VISE. A TDS DELIVERY WIRE AND A SEPARATED PDA COIL WERE RETURNED. ON THE TDS THE THREAD HAD ELONGATED AND THE STRAIGHTENING MANDRIL INSIDE COULD NOT BE MOVED. A SMALL THREAD-LIKE PIECE WAS FASTENED TO THE TDS 19MM FROM THE DISTAL TIP. HOWEVER, UNFORTUNATELY THIS PIECE WAS LOST DURING THE INVESTIGATION BEFORE BEING IDENTIFIED. ON THE COIL THE MOST DISTAL PART OF THE THREAD WAS MISSING AS IF CUT, THE MOST DISTAL SEVEN WINDINGS WERE ACCORDING TO SPECIFICATIONS, AND THE NEXT SIX WINDINGS WERE SEVERELY ELONGATED. IMMEDIATELY, IT CANNOT BE DETERMINED EXACTLY HOW OR WHEN IN TIME THE THREAD HAD SEPARATED, BUT A DETAILED SCANNING ELECTRON MICROSCOPY ANALYSIS DID NOT REVEAL ANY SIGN OF MATERIAL NON-CONFORMANCE. NO IMAGING WAS PROVIDED, NOR COULD ADDITIONAL INFORMATION BE OBTAINED AND BASED ON THE INVESTIGATION FINDINGS IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE CAUSED THE DIFFICULTIES ENCOUNTERED WHEN ATTEMPTING TO DETACH THE COILS. HOWEVER, THE INSTRUCTIONS FOR USE CAUTION THAT IN CASE OF DIFFICULTIES WITH DETACHING THE COIL, THE GUIDING CATHETER AND THE DELIVERY WIRE MUST BE REMOVED WITH THE COIL SIMULTANEOUSLY AND THE WHOLE SYSTEM MUST BE REPLACED. THE IFU ALS CAUTION THAT THE STRAIGHTENING MANDRIL MUST BE AT THE TIP OF THE COIL DURING THE PROCEDURE, OTHERWISE THE COIL MAY START COILING UP INSIDE THE CATHETER, THUS COMPLICATING THE COIL DETACHMENT. HOWEVER, THERE IS NO INFORMATION CONCERNING THE CATHETER USED, BUT THE IFU RECOMMEND THE USE OF A 5FR, NON-TAPERED, END HOLE ONLY, MULTIPURPOSE HEART CATHETER WITH MIN. LUMEN .041 INCHES TO OBTAIN STABILITY DURING COIL INTRODUCTION. NO EVIDENCE TO SUGGEST PRODUCT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: 2 FLIPPER COILS (IMWCE-3-PDA5) DIDN'T DETACH FROM THE DELIVERY SYSTEM, ONE GOT CAUGHT. THE PROBLEM WAS, THAT TWO FLIPPER COILS WERE NOT POSSIBLE TO DETACH FROM THE TDS SYSTEM. FIRST COIL WAS NOT POSSIBLE TO DETACH (THEY FLUSHED THE COIL), THEY CHANGE THEM INTO A NEW/ SECOND COIL. THIS SECOND COIL ALSO NOT POSSIBLE TO DETACH FROM THE SYSTEM BECAUSE THE COIL AND THE TDS CATHETER GET CAUGHT AND TWISTED, SLIPS IN AORTA AND HERE THEY DETACH WITH DIFFICULTY THE COIL FROM TDS. THE COILS DISSOCIATED IN FREE AORTA BUT THEY CATCH THEM WITH A SNARE. PATIENT OUTCOME: PATIENT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 609982 | FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM | KRD DEVICE, EMBOLIZATION, VASCULAR | KRD | WILLIAM COOK EUROPE | E3986957 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |