PENUMBRA COIL 400
Report
- Report Number
- 3005168196-2015-00610
- Event Type
- Malfunction
- Date Received
- June 18, 2015
- Date of Event
- May 22, 2015
- Report Date
- May 22, 2015
- Manufacturer
- PENUMBRA, INC.
- Product Code
- HCG
- PMA / PMN Number
- K120330
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2015-00606, 00607, 00608 AND 00609.
(B)(6). EVENT DESCRIPTION EDITED. MANUFACTURE DATE: 02/08/2014.
RESULTS: [-1] THE FIRST PX SLIM WAS KINKED APPROXIMATELY 2.5 CM FROM THE HUB; [-2] THERE WAS NO VISIBLE DAMAGE TO THE SECOND PX SLIM. [-3] THE FIRST PC400 COIL WAS DETACHED FROM ITS PUSHER ASSEMBLY; THIS PUSHER ASSEMBLY WAS NOT RETURNED FOR EVALUATION. [-4] THE PET LOCK OF THE SECOND PC400 COIL EVALUATED WAS INTACT ON THE PROXIMAL END OF THE PUSHER ASSEMBLY; THE PUSHER ASSEMBLY WAS KINKED APPROXIMATELY 16.0 CM FROM THE PROXIMAL END; THE PULL WIRE WAS INSIDE THE DISTAL DETACHMENT TIP (DDT) CAPTURE FEATURE; THE COIL WAS DETACHED FROM THE PUSHER ASSEMBLY AND DAMAGED. [-5] THE PET LOCK OF THE THIRD PC400 COIL EVALUATED WAS INTACT ON THE PROXIMAL END OF THE PUSHER ASSEMBLY; THE PUSHER ASSEMBLY WAS KINKED APPROXIMATELY 5.0 CM FROM THE PROXIMAL END; THE COIL WAS INTACT WITH THE PUSHER ASSEMBLY. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATED THAT DURING THE PROCEDURE, THE PHYSICIAN MET DIFFICULTY WHILE ADVANCING A PC400 COIL THROUGH A PX SLIM. WHILE RESHEATHING THIS PC400 COIL, IT UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THE PHYSICIAN REMOVED AND REPLACED THE PX SLIM WITH A NEW ONE. THE PHYSICIAN MET RESISTANCE WHILE ADVANCING A NEW PC400 COIL THROUGH THE NEW PX SLIM AND THE PC400 COIL WAS REMOVED. A NEW PC400 COIL WAS USED AND PARTIALLY DEPLOYED IN THE ANEURYSM; HOWEVER, RESISTANCE WAS MET. THE PHYSICIAN SUCCESSFULLY REMOVED THE PC400 COIL AND THE PROCEDURE THEN CONTINUED USING A NON-PENUMBRA COIL. EVALUATION OF THE RETURNED DEVICES REVEALED A KINK IN THE [-1] FIRST PX SLIM. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO IMPROPER HANDLING DURING REMOVAL FROM PACKAGING OR USE. IF THE PX SLIM IS MANIPULATED WITH FORCE AT AN ANGLE DURING REMOVAL FROM THE PACKAGING HOOP, OR DURING USE, IT IS LIKELY THAT DAMAGE SUCH AS THIS WILL OCCUR. [-3] THE PUSHER ASSEMBLY OF THE FIRST PC400 COIL WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE FAILURE OF THIS DEVICE COULD NOT BE DETERMINED. FURTHER EVALUATION REVEALED KINKS IN [-4,-5] THE TWO REMAINING PC400 COILS' PUSHER ASSEMBLIES. THESE KINKS TYPICALLY OCCUR DUE TO IMPROPER HANDLING DURING USE. IF THE DEVICES ARE MANIPULATED AGAINST RESISTANCE AT AN ANGLE, IT IS LIKELY THAT DAMAGE SUCH AS THIS MAY OCCUR. FURTHER EVALUATION REVEALED THAT [-4] ONE OF THE PC400 COILS WAS UNINTENTIONALLY DETACHED FROM ITS PUSHER ASSEMBLY. THIS UNINTENTIONAL DETACHMENT OCCURRED DESPITE THE FACT THAT THE PULL WIRE WAS STILL INTACT WITH THE DDT CAPTURE FEATURE. THIS FAILURE LIKELY OCCURRED FROM THE PUSHER ASSEMBLY BEING RETRACTED AGAINST RESISTANCE, WHICH ALLOWED THE DDT TO EXTEND BEYOND THE REACH OF THE PULL WIRE AND RESULTED IN THE COIL DETACHING. THE DIFFICULTIES/RESISTANCE THAT WAS EXPERIENCED DURING THE ADVANCING OF THE COILS COULD HAVE BEEN CAUSED BY THE DAMAGE TO THE PX SLIM AND THE COIL BEING DAMAGED DURING IMPROPER MANIPULATION. THE COILS ARE 100% FUNCTIONALLY TESTED AND VISUALLY INSPECTED FOR DAMAGE DURING PROCESS INSPECTION. THE CATHETERS ARE 100% VISUALLY INSPECTED FOR DAMAGE DURING PROCESS INSPECTION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PX SLIM DELIVERY MICROCATHETER AND PENUMBRA COIL 400 (PC400) COILS. DURING THE PROCEDURE, THE PHYSICIAN MET DIFFICULTY WHILE ADVANCING A PC400 COIL THROUGH THE SLIM MICROCATHETER. WHILE RESHEATHING THE PC400 COIL IT UNINTENTIONALLY DETACHED INSIDE THE SLIM MICROCATHETER. THE PHYSICIAN REMOVED THE SLIM MICROCATHETER WITH THE DETACHED PC400 COIL INSIDE AND THE PROCEDURE CONTINUE USING NEW SLIM MICROCATHETER. THE PHYSICIAN MET A RESISTANCE WHILE ADVANCING A NEW PC400 COIL THROUGH THE SLIM MICROCATHETER AND IT WAS REMOVED. A NEW PC400 COIL WAS USED AND PARTIALLY DEPLOYED IN THE ANEURYSM; HOWEVER, RESISTANCE WAS MET. THE PHYSICIAN SUCCESSFULLY REMOVED THE PC400 COIL AND THE PROCEDURE SUCCESSFULLY CONTINUED USING A NEW PENUMBRA COIL 400 COIL AND THE SAME SLIM MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PX SLIM DELIVERY MICROCATHETER AND PENUMBRA COIL 400 (PC400) COILS. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE PATIENT HAD VERY TORTUOUS ANATOMY. THE PHYSICIAN THEN MET DIFFICULTY WHILE ADVANCING A PC400 COIL THROUGH THE SLIM MICROCATHETER. WHILE RESHEATHING THE PC400 COIL IT UNINTENTIONALLY DETACHED INSIDE THE SLIM MICROCATHETER. THE PHYSICIAN REMOVED THE SLIM MICROCATHETER WITH THE DETACHED PC400 COIL INSIDE AND THE PROCEDURE CONTINUED USING NEW SLIM MICROCATHETER. THE PHYSICIAN MET A RESISTANCE WHILE ADVANCING A NEW PC400 COIL THROUGH THE SLIM MICROCATHETER AND IT WAS REMOVED. A NEW PC400 COIL WAS USED AND PARTIALLY DEPLOYED IN THE ANEURYSM; HOWEVER, RESISTANCE WAS MET. THE PHYSICIAN DECIDED TO REMOVE THE PC400 COIL AND THE PROCEDURE CONTINUED USING ANOTHER MANUFACTURERS COIL AND MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 397275 | PENUMBRA COIL 400 | HCG, KRD | HCG | PENUMBRA, INC. | F41331 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |