POLARIS DX¿ STEERABLE DIAGNOSTIC CATHETER
Report
- Report Number
- 2134265-2011-03330
- Event Type
- Malfunction
- Date Received
- July 28, 2011
- Date of Event
- July 4, 2011
- Report Date
- July 4, 2011
- Manufacturer
- BOSTON SCIENTIFIC - SAN JOSE
- Product Code
- DRF
- PMA / PMN Number
- K924163
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
DEVICE EVALUATED BY MFR: VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THE DISTAL TUBING WAS FOUND SEPARATED FROM THE MAIN SHAFT OF THE CATHETER (PROXIMAL SHAFT BUTT BOND), EXPOSING THE INNER SPRING COIL. THE SPRING COIL WAS FOUND EXPOSED APPROXIMATELY 0.8700" IN LENGTH. THE DISTAL SECTION WAS FOUND STILL REMAINED CONNECTED TO THE MAIN BODY. THE BREAK HAD OCCURRED WHERE THE DISTAL TUBING AND THE MAIN BODY SECTIONS ARE JOINED TOGETHER (BUTT BOND). TRACES OF GLUE WERE SEEN ON THE DRAW DOWN AREA OF THE DISTAL TUBING. DRIED BLOOD WAS ALSO FOUND ON THE CATHETER'S TUBING SHAFT AND INSIDE THE DISTAL ASSEMBLY. TO FURTHER INVESTIGATE, THE MAIN BODY (PROXIMAL TUBING) WAS CUT NEAR THE BUTT BOND AREA. THE SPRING COIL WAS PULLED FROM THE MAIN BODY (PROXIMAL TUBING). THEN, THE MAIN BODY (PROXIMAL TUBING) WAS DISSECTED. DURING VISUAL INSPECTION OF THE MAIN BODY (PROXIMAL TUBING) WITH A MICROSCOPE, TRACES OF GLUE WERE SEEN INSIDE THE TUBING NEAR THE BUTT BOND AREA. IN ADDITION, THE MONEL SAFETY WIRE WAS OBSERVED LIFTING FROM THE DRAW DOWN. THE DRAW DOWN ON THE DISTAL TUBING WAS THEN DISSECTED. THE DISTAL TUBING AND THE MAIN BODY (PROXIMAL TUBING) WERE VISUALLY INSPECTED WHERE THE BREAK HAD OCCURRED (BUTT BOND), AND FOUND GLUE ON BOTH ENDS OF THE DISTAL TUBING AND THE MAIN BODY (PROXIMAL TUBING). INSPECTION OF THE INTERNAL COMPONENTS CONFIRMED THAT THE DEVICE WAS BUILT PER MANUFACTURING AND PRODUCT SPECIFICATIONS - NO ANOMALIES WERE OBSERVED. THE HANDLE VERIFIED NORMAL DURING VISUAL INSPECTION. THE ELECTRICAL CONNECTOR WAS INTACT. THERE WAS NO OTHER PHYSICAL DAMAGES OBSERVED IN THE UNIT DURING ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).
IT WAS REPORTED THAT DURING AN ELECTROPHYSIOLOGY PROCEDURE THE TIP SEPARATED. THE PROCEDURE WAS INDICATED TO UPGRADE THE PATIENT'S CURRENT DDD PACEMAKER TO A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). ACCESS WAS OBTAINED VIA THE SUBCLAVIAN ARTERY. A POLARIS DX STEERABLE DIAGNOSTIC CATHETER WAS INSERTED INTO A NON-BSC DELIVERY SYSTEM WHEN THE PHYSICIAN NOTICED THAT THE INSULATION AT THE TIP OF THE POLARIS CATHETER WAS SEPARATED FROM THE INSULATION COVERING THE REMAINDER OF THE DEVICE. THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE
IT WAS REPORTED THAT DURING AN ELECTROPHYSIOLOGY PROCEDURE THE TIP SEPARATED. THE PROCEDURE WAS INDICATED TO UPGRADE THE PATIENT'S CURRENT DDD PACEMAKER TO A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). ACCESS WAS OBTAINED VIA THE SUBCLAVIAN ARTERY. A POLARIS DX STEERABLE DIAGNOSTIC CATHETER WAS INSERTED INTO A NON-BSC DELIVERY SYSTEM WHEN THE PHYSICIAN NOTICED THAT THE INSULATION AT THE TIP OF THE POLARIS CATHETER WAS SEPARATED FROM THE INSULATION COVERING THE REMAINDER OF THE DEVICE. THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLARIS DX¿ STEERABLE DIAGNOSTIC CATHETER | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | DRF | BOSTON SCIENTIFIC - SAN JOSE | M0045572S0 | 14063525 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | ACUITY BREAK-AWAY |