STERLING BALLOON DILATATION CATHETER
Report
- Report Number
- 2134265-2010-04419
- Event Type
- Injury
- Date Received
- September 23, 2010
- Date of Event
- August 27, 2010
- Report Date
- September 2, 2010
- Manufacturer
- BOSTON SCIENTIFIC - MAPLE GROVE
- Product Code
- DQY
- PMA / PMN Number
- K053116
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- PHYSICIAN
Narratives
AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).
DEVICE EVALUATED BY MFR: VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE REVEALED THERE WAS DRIED BLOOD IN THE SHAFT. VISUAL AND TACTILE INSPECTION OF THE SHAFT REVEALED A SEPARATION LOCATED APPROXIMATELY 76 CM FROM THE STRAIN RELIEF AND SHAFT DAMAGE 69 CM FROM THE STRAIN RELIEF. THE PORTION OF THE DEVICE DISTAL TO THE SEPARATION, INCLUDING THE BALLOON AND DISTAL TIP, WERE NOT RECEIVED FOR ANALYSIS. EXAMINATION OF THE MATERIAL SURROUNDING THE SEPARATION AND DAMAGE DID NOT REVEAL ANY EVIDENCE OF MATERIAL OR MANUFACTURING DEFICIENCIES THAT WOULD HAVE CONTRIBUTED TO THE INCIDENT. MICROSCOPIC INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. 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).
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE REMOVAL DIFFICULTIES OCCURRED. ACCESS WAS OBTAINED VIA AN UNSPECIFIED LEFT ARTERY WITH A CONTRALATERAL APPROACH INITIATED ACROSS THE AORTIC ILIAC BIFURCATION. THE LESION WAS IN THE RIGHT ILIAC ARTERY. AN F/G STERLING OTW 8.0 X 40/80 (4F) BALLOON CATHETER WAS INFLATED AND ABLE TO SUCCESSFULLY TREAT THE TARGET LESION. THE BALLOON WAS DEFLATED IN THE "USUAL" MANNER; HOWEVER, THE PHYSICIAN WAS NOT ABLE TO PULL THE DEVICE BACK AS THE DEVICE WAS SNAGGED ON A CALCIFIED PORTION OF THE LESION. THE DEVICE WAS ABLE TO BE ADVANCED FORWARD. AFTER NUMEROUS UNSUCCESSFUL ATTEMPTS TO REMOVE THE BALLOON CATHETER, THE PHYSICIAN GAINED ACCESS THROUGH THE OPPOSITE FEMORAL ARTERY, ADVANCED A SNARE OVER THE BALLOON, PULLED THE BALLOON PORTION OF THE CATHETER OUT OF THE PATIENT AND CUT THE DEVICE. THE REMAINDER OF THE BALLOON WAS ABLE TO BE PULLED BACK THROUGH THE SHEATH. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.
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
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STERLING BALLOON DILATATION CATHETER | CATHETER, PERCUTANEOUS | DQY | BOSTON SCIENTIFIC - MAPLE GROVE | H74939032804080 | 13397864 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |