KINETIX PTCA GUIDEWIRE
Report
- Report Number
- 2134265-2010-05387
- Event Type
- Malfunction
- Date Received
- December 29, 2010
- Date of Event
- August 4, 2010
- Report Date
- August 4, 2010
- Manufacturer
- BOSTON SCIENTIFIC - MAPLE GROVE
- Product Code
- DQX
- PMA / PMN Number
- K081021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE EVALUATED BY MANUFACTURER EXAMINATION OF THE RETURNED KINETIX GUIDE WIRE REVEALED THAT A MAJORITY OF THE SOLDER ON THE DISTAL TIP WAS MISSING. THERE ARE NOTICEABLE AMOUNTS OF DRIED BLOOD AND CONTRAST MEDIA PRESENT ALONG THE ENTIRE LENGTH OF THE UNIT. ALONG WITH THE CONTRAST MEDIA VARIOUS PIECES OF FOREIGN MATERIAL COULD BE SEEN ALONG THE HIGH TORQUE SLEEVE (HTS). THE FOREIGN MATTER WAS LOOSE AND PROTRUDING OUT OF THE HTS. THE HTS WAS CUT ~ 2 INCHES FROM THE DISTAL TIP TO REVEAL THE INTERNAL COMPONENTS. DUE TO THE LARGE AMOUNTS OF DRIED BLOOD AND CONTRAST MEDIA PRESENT, THE HTS WAS NOT ABLE TO BE REMOVED EASILY. WHILE ATTEMPTING TO REMOVE THE HTS, THE COIL SEPARATED FROM THE CCR JOINT (SOLDER JOINT COIL/CORE/RIBBON). THE DISTAL END OF THE DEVICE WAS SOAKED IN WATER TO DISSOLVE AND DISLODGE SOLIDIFIED BLOOD AND CONTRAST FROM BETWEEN THE MICROCUTS OF THE HTS. AFTER SOAKING, THE HTS WAS CUT PROXIMAL TO THE DISTAL TIP. THE RIBBON WAS REMOVED AND EXAMINED, EVIDENCE OF SOLDER ON THE DISTAL PORTION WAS FOUND. THIS IS CONSISTENT WITH THE RIBBON HAVING BEEN PULLED OUT OF THE DISTAL TIP SOLDER. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).
(B)(4).
REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, TIP DAMAGE AND REMOVAL DIFFICULTIES OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A KINETIX GUIDE WIRE WAS ADVANCED AND A MACH1 GUIDE CATHETER ENGAGED THE VESSEL. DURING THE PROCEDURE, A TAXUS LIBERTE STENT WAS DEPLOYED. WHEN REMOVING THE KINETIX GUIDE WIRE THERE WAS RESISTANCE AND THE MACH1 GUIDE CATHETER WAS DEEP SEATED. THE KINETIX GUIDE WIRE WAS REMOVED FROM THE LESION SEPARATELY FROM THE GUIDE CATHETER WITHOUT ANY ADDITIONAL INTERVENTION. THE PHYSICIAN STATED THAT THE DISTAL TIP OF THE KINETIX GUIDE WIRE WAS FLARED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S STATUS IS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED THAT A PART OF THE SOLDER WAS MISSING.
REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, TIP DAMAGE AND REMOVAL DIFFICULTIES OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A KINETIX GUIDE WIRE WAS ADVANCED AND A MACH1 GUIDE CATHETER ENGAGED THE VESSEL. DURING THE PROCEDURE, A TAXUS LIBERTE STENT WAS DEPLOYED. WHEN REMOVING THE KINETIX GUIDE WIRE THERE WAS RESISTANCE AND THE MACH1 GUIDE CATHETER WAS DEEP SEATED. THE KINETIX GUIDE WIRE WAS REMOVED FROM THE LESION SEPARATELY FROM THE GUIDE CATHETER WITHOUT ANY ADDITIONAL INTERVENTION. THE PHYSICIAN STATED THAT THE DISTAL TIP OF THE KINETIX GUIDE WIRE WAS FLARED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S STATUS IS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED THAT A PART OF THE SOLDER WAS MISSING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINETIX PTCA GUIDEWIRE | WIRE, GUIDE, CATHETER | DQX | BOSTON SCIENTIFIC - MAPLE GROVE | H74939122010 | 13375983 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | MACH1 GUIDE CATHETER| TAXUS LIBERTE STENT |