TREK CORONARY DILATATION CATHETER
Report
- Report Number
- 2024168-2010-02959
- Event Type
- Malfunction
- Date Received
- December 23, 2010
- Date of Event
- November 16, 2010
- Report Date
- November 17, 2010
- Manufacturer
- AV-TEMECULA-CT
- Product Code
- LOX
- PMA / PMN Number
- P810046
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
(B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DILATATION CATHETER: TREK, TERUMO RYUJIN PLUS 2X15MM; GUIDE WIRE: HI-TORQUE PILOT H, WHISPER; GUIDE CATH: SHERPA ACTIVE 3.75 EBU; STENT: XIENCE PRIME LL (LOT 0021741). EVALUATION SUMMARY: EVALUATION OF THE RETURNED TREK DILATATION CATHETER NOTED THE BALLOON WAS RETURNED PARTIALLY FILLED WITH CONTRAST. THERE WERE KINKS IN THE HYPOTUBE 5.5 CM AND 23.5 CM DISTAL TO THE STRAIN RELIEF TUBING. THE BALLOON HAD ROLLED DISTALLY OVER THE TIP. THE INNER MEMBER INSIDE THE BALLOON WAS IN A S SHAPE. THE SHAFT INNER AND OUTER MEMBER WAS KINKED, FLATTENED AND STRETCHED 5.5 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH FOR A LENGTH OF 10 CM. THE INNER MEMBER WAS FLATTENED AND THE OUTER MEMBER WAS BUNCHED FOR A LENGTH OF 5MM PROXIMAL TO THE PROXIMAL SEAL. THE PROXIMAL BALLOON MARKER BAND WAS LOCATED 2MM PROXIMAL TO THE PROXIMAL SEAL. THE BALLOON CATHETER WAS WITHDRAWN FROM THE NON-ABBOTT GUIDING CATHETER AND THERE WAS NO RESISTANCE NOTED. AN ATTEMPT WAS MADE TO DEFLATE THE BALLOON BUT THE BALLOON COULD NOT BE DEFLATED; THEREFORE, THE BALLOON CATHETER WAS NOT ADVANCED THROUGH THE NON-ABBOTT GUIDING CATHETER. THE DEFLATION TIMES COULD NOT BE MEASURED SINCE THE BALLOON WOULD NOT DEFLATE. THE NOTED DAMAGE TO THE CATHETER IS CONSISTENT WITH DAMAGE THAT WOULD OCCUR DURING RETRACTION IF RESISTANCE WAS ENCOUNTERED. ADDITIONALLY, THE NOTED STRETCHING OF THE SHAFT LIKELY CONTRIBUTED TO THE BALLOON BEING UNABLE TO DEFLATE. THE DAMAGES NOTED DO NOT SUGGEST A PRODUCT DEFICIENCY. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT.
(B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DILATATION CATHETER: TREK, TERUMO RYUJIN PLUS 2X15MM; GUIDE WIRE: HI-TORQUE PILOT H, WHISPER; GUIDE CATH: SHERPA ACTIVE 3.75 EBU; STENT: XIENCE PRIME LL (LOT 0021741). EVALUATION SUMMARY: EVALUATION OF THE RETURNED TREK DILATATION CATHETER NOTED THE BALLOON WAS RETURNED PARTIALLY FILLED WITH CONTRAST. THERE WERE KINKS IN THE HYPOTUBE 5.5 CM AND 23.5 CM DISTAL TO THE STRAIN RELIEF TUBING. THE BALLOON HAD ROLLED DISTALLY OVER THE TIP. THE INNER MEMBER INSIDE THE BALLOON WAS IN A S SHAPE. THE SHAFT INNER AND OUTER MEMBER WAS KINKED, FLATTENED AND STRETCHED 5.5 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH FOR A LENGTH OF 10 CM. THE INNER MEMBER WAS FLATTENED AND THE OUTER MEMBER WAS BUNCHED FOR A LENGTH OF 5MM PROXIMAL TO THE PROXIMAL SEAL. THE PROXIMAL BALLOON MARKER BAND WAS LOCATED 2MM PROXIMAL TO THE PROXIMAL SEAL. THE BALLOON CATHETER WAS WITHDRAWN FROM THE NON-ABBOTT GUIDING CATHETER AND THERE WAS NO RESISTANCE NOTED. AN ATTEMPT WAS MADE TO DEFLATE THE BALLOON BUT THE BALLOON COULD NOT BE DEFLATED; THEREFORE, THE BALLOON CATHETER WAS NOT ADVANCED THROUGH THE NON-ABBOTT GUIDING CATHETER. THE DEFLATION TIMES COULD NOT BE MEASURED SINCE THE BALLOON WOULD NOT DEFLATE. THE NOTED DAMAGE TO THE CATHETER IS CONSISTENT WITH DAMAGE THAT WOULD OCCUR DURING RETRACTION IF RESISTANCE WAS ENCOUNTERED. ADDITIONALLY, THE NOTED STRETCHING OF THE SHAFT LIKELY CONTRIBUTED TO THE BALLOON BEING UNABLE TO DEFLATE. THE DAMAGES NOTED DO NOT SUGGEST A PRODUCT DEFICIENCY. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT.
(B)(4). ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE ON THE SHAFT AND BALLOON AND IN THE GUIDE WIRE LUMEN. THERE WAS CONTRAST IN THE INFLATION LUMEN AND IN THE BALLOON. THE BALLOON WAS RETURNED PARTIALLY FILLED WITH CONTRAST. THE BALLOON CATHETER WAS RETURNED INSIDE A NON-ABBOTT GUIDING CATHETER AND WAS INSERTED THROUGH A NON-ABBOTT ROTATING HEMOSTATIC VALVE (RHV). THERE WAS 48.3CM OF THE PROXIMAL END OF THE BALLOON CATHETER EXTENDING OUT THE PROXIMAL END OF THE GUIDING CATHETER. THERE WERE KINKS IN THE HYPOTUBE SHAFT 5.5CM AND 23.5CM DISTAL TO THE STRAIN RELIEF TUBING. THE BALLOON HAD ROLLED DISTALLY OVER THE TIP. THE INNER MEMBER INSIDE THE BALLOON WAS IN AN S SHAPE. THE SHAFT INNER AND OUTER MEMBERS WERE KINKED, FLATTENED AND STRETCHED 5.5CM DISTAL TO THE GUIDE WIRE EXIT NOTCH FOR A LENGTH OF 10CM. THE INNER MEMBER WAS FLATTENED AND THE OUTER MEMBER WAS BUNCHED FOR A LENGTH OF 5MM PROXIMAL TO THE PROXIMAL SEAL. THE PROXIMAL BALLOON MARKER BAND WAS LOCATED 2MM PROXIMAL TO THE PROXIMAL SEAL DUE TO THE BALLOON FOLDED OVER ITSELF. THE GUIDING CATHETER WAS RETURNED WITH BLOOD INSIDE THE GUIDING CATHETER. THE TIP OF THE GUIDING CATHETER WAS FLATTENED 0.8CM PROXIMAL TO THE TIP FOR A LENGTH OF 2.5CM AND WAS IN A HOOK SHAPE. THERE WAS A KINK IN THE SHAFT OF THE GUIDING CATHETER 16CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS A WHISPER GUIDE WIRE RETURNED WITH THE BALLOON CATHETER. THERE WAS BLOOD AND CONTRAST VISIBLE ON THE CORE AND POLYMER COATING. THERE WERE BENDS IN THE CORE 46CM AND 85CM DISTAL TO THE PROXIMAL END OF THE GUIDE WIRE. THERE WERE KINKS IN THE CORE 7.7CM AND 16.5CM DISTAL TO THE PROXIMAL END OF THE POLYMER COATING. THE TIP OF THE GUIDE WIRE WAS IN A HOOK SHAPE AND THERE WERE MULTIPLE KINKS SPORADICALLY IN THE TIP FOR A LENGTH OF 2CM PROXIMAL TO THE TIP BALL. POSSIBLE CAUSES FOR DIFFICULTY IN REMOVING A DILATATION CATHETER AFTER INFLATION MAY INCLUDE THE BALLOON NOT BEING FULLY DEFLATED PRIOR TO ATTEMPTING TO REMOVE THE BALLOON FROM THE VESSEL, DAMAGE TO THE BALLOON, KINKS, BENDS, OBSTRUCTIONS IN THE GUIDING CATHETER LUMEN, DAMAGE TO THE GUIDING CATHETER OR INTRODUCER SHEATH. THE INNER DIAMETER OF THE NON-ABBOTT GUIDING CATHETER WAS MEASURED WITH A .070 INCH PIN GAUGE. THE PIN GAUGE WAS ONLY ABLE TO ADVANCE THROUGH THE TIP UP TO THE FLATTENED SHAFT OF THE GUIDING CATHETER. THE BALLOON CATHETER WAS WITHDRAWN FROM THE NON-ABBOTT GUIDING CATHETER AND THERE WAS NO RESISTANCE NOTED. A NEW INDEFLATOR FILLED WITH RENOGRAFIN 60 DILUTED 1:1 WITH WATER WAS USED TO PRESSURIZE THE BALLOON. THE BALLOON WAS ABLE TO BE PRESSURIZED ENOUGH TO ALLOW THE BALLOON TO UNROLL FROM OVER THE TIP. AN ATTEMPT WAS MADE TO DEFLATE THE BALLOON BUT THE BALLOON COULD NOT BE DEFLATED THEREFORE THE BALLOON CATHETER WAS NOT ADVANCED THROUGH THE NON-ABBOTT GUIDING CATHETER. IN THIS CASE, IT IS LIKELY THAT THE CATHETER AND WIRE WERE KINKED WITHIN THE PATIENTS ANATOMY DUE TO THE SEVERE 90 DEGREE BEND. IT IS POSSIBLE THE GUIDE CATHETER COULD HAVE BECOME DAMAGED (KINKING AT THE DISTAL TIP) DUE TO THE PRESSURE OF DELIVERING THE WIRE AND BALLOON CATHETER; HOWEVER IT IS ALSO POSSIBLE THAT THE BALLOON DAMAGED THE GUIDE IN ATTEMPTS TO REMOVE THE BALLOON CATHETER. IF THE BALLOON CATHETER WAS KINKED, IT COULD HAVE DEFLATED SLOWLY OR HAVE AN INCOMPLETE DEFLATION WHICH CAUSED THE INABILITY TO REMOVE THE BALLOON THROUGH THE GUIDE. THE NOTED DAMAGE TO THE CATHETER IS CONSISTENT WITH DAMAGE THAT WOULD OCCUR DURING RETRACTION IF RESISTANCE WAS ENCOUNTERED. ADDITIONALLY, THE NOTED STRETCHING OF THE SHAFT MAY HAVE ALSO CONTRIBUTED TO THE BALLOON BEING UNABLE TO DEFLATE DURING RETURN ANALYSIS. A CINE OF THE PROCEDURE WAS RECEIVED AND REVIEWED BY AN ABBOTT CLINICAL SPECIALIST. THE REVIEWER NOTED A GUIDE WIRE, WHICH IS ASSUMED TO BE THE WHISPER GUIDE WIRE NOTED IN THE CASE REPORT SEEN IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A SEVERE MID LAD LESION WITH DIFFUSE DISEASE TO THE SEVERE LESION IS ALSO NOTED. IT IS OBVIOUS THAT AT THE AREA OF THE SEVERE LESION A 90 DEGREE TURN IN THE VESSEL IS PRESENT AND PRESENTS A PRETTY SEVERE TORTUOSITY THAT THE DEVICES MUST TRAVERSE. THE REVIEWER NOTED A BALLOON CATHETER IS SEEN IN THE MID LAD TREATING THE SEVERE LESION. IT APPEARS TO BE A SHORTER BALLOON AND IS NOT BELIEVED TO BE THE TREK BALLOON CATHETER IN QUESTION. A LONGER BALLOON CATHETER IS PRESENT IN THE LAD TREATING THE AREA IMMEDIATELY DISTAL TO THE SEVERE TORTUOSITY AND WHICH IS LIKELY TO BE THE 30MM TREK BALLOON CATHETER. INFLATION IS NOTED AND LOOKS SYMMETRICAL. A SECOND INFLATION OF THE FIRST TREK BALLOON CATHETER OR THE SECOND TREK BALLOON CATHETER INTRODUCED IS SEEN WITH MOVEMENT OF THE BALLOON CATHETER MORE DISTAL IN THE PATIENT ANATOMY. AN ANGIOGRAM OF THE LAD WITH THE WIRE PRESENT AND THE CATHETERS REMOVED SHOWS A GOOD RESULT. A STENT IS THEN SEEN DEPLOYED WITH SYMMETRICAL INFLATION. ANOTHER ANGIOGRAM SHOWS THE TREATED LESION WITH GOOD RESULTS. THE REVIEWER CONCLUDED THAT IT IS NOT CLEAR IF THIS ISSUE WAS RESULTANT OF THE KINKING OF THE DISTAL TIP OF THE NON-ABBOTT GUIDE CATHETER OR IF IT IS DUE TO INCOMPLETE DEFLATION OF THE TREK CATHETER. DUE TO THE TORTUOSITY PRESENT IN THE ANATOMY, HOWEVER, IT IS FORESEEABLE THAT THE ISSUE COULD HAVE BEEN RESULTANT FROM THE KINKING OF THE TREK CATHETER AND THAT ONLY PARTIAL DEFLATION OCCURRED CAUSING THE DIFFICULTIES IN REMOVAL OF THE TREK BALLOON CATHETER THROUGH THE GUIDE CATHETER. IN THIS CASE, THE REPORTED DIFFICULTY REMOVING THE BALLOON CATHETER APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THE PROFILE DIMENSIONS ON ALL DILATATION CATHETERS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ADDITIONALLY, ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED ONLINE FOR DAMAGE.
IT WAS REPORTED THAT AFTER PRE-DILATATION OF A PROCEDURE TO TREAT THE DISTAL, MID LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION, THE TREK BALLOON WAS USED TO FURTHER PRE-DILATATE THE LESION WITH 2 INFLATIONS AT 16 ATMOSPHERE (ATM)FOR 45 SECONDS. DURING RETRACTING OF THE TREK BALLOON IT BECAME 'BLOCKED". THE DEVICE WAS REMOVED FROM THE ANATOMY INSIDE THE GUIDE CATHETER AND ON THE GUIDE WIRE. A SECOND TREK BALLOON AND A XIENCE PRIME LL 2.5X33 MM STENT DELIVERY SYSTEM WERE USED IN THE PROCEDURE. THERE WAS NO REPORTED PATIENT EFFECT. NO ADDITIONAL INFORMATION PROVIDED. DEVICE ANALYSIS REVEALED THE BALLOON WAS PARTIALLY FILLED WITH CONTRAST AND THE SHAFT INNER MEMBER WAS FLATTENED.
SUBSEQUENT TO FILING THE FIRST MDR, THE CINE CD WAS RECEIVED AND ANALYZED BY A CLINICAL SPECIALIST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TREK CORONARY DILATATION CATHETER | CORONARY DILATATION CATHETER | LOX | AV-TEMECULA-CT | 0060162 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |