STERLING ES PTA BALLOON DILATATION CATHETER
Report
- Report Number
- 2134265-2011-00945
- Event Type
- Malfunction
- Date Received
- March 17, 2011
- Date of Event
- February 22, 2011
- Report Date
- February 23, 2011
- Manufacturer
- BOSTON SCIENTIFIC - MAPLE GROVE
- Product Code
- LIT
- PMA / PMN Number
- K080982
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE EVALUATED BY MFR: RETURNED PRODUCT ANALYSIS REVEALED DRIED BLOOD AND CONTRAST WERE PRESENT IN THE GUIDE WIRE LUMEN. THE BALLOON CATHETER WAS RETURNED IN A DEFLATED STATE. THE BALLOON WAS INSPECTED UNDER MAGNIFICATION. A PINHOLE WAS CONFIRMED IN THE BALLOON WALL < 1 MM FROM THE PROXIMAL SIDE OF THE DISTAL MARKERBAND. INSPECTION OF THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKERS THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. THERE IS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. 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).
AGE AT TIME OF EVENT: (B)(6). (B)(4).
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TO SEVERELY CALCIFIED AND MODERATELY TORTUOUS RIGHT ANTERIOR TIBIAL ARTERY. A JOURNEY GUIDE WIRE WAS PLACED ACROSS THE LESION AND THE 2MM X 40MM STERLING BALLOON CATHETER WAS ADVANCED FOR PRE-DILATION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 2ATMS AND A LEAK WAS NOTED. THE DEVICE WAS EXCHANGED FOR A 2.5MM X 40MM STERLING BALLOON WHICH WAS INFLATED THREE TIMES. A 2.0MM X 15MM SPCB FLEXTOME CATHETER WAS THEN INSERTED AND DIFFICULTY WAS REPORTED WHILE ADVANCING TO THE LESION. DURING THE FIRST INFLATION, THE SPCB RUPTURED AT 2ATMS. ADDITIONAL DILATIONS WERE PERFORMED WITH THE 2.5MM X 40MM STERLING BALLOON AND ANOTHER 2.0 SPCB TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD.
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TO SEVERELY CALCIFIED AND MODERATELY TORTUOUS RIGHT ANTERIOR TIBIAL ARTERY. A JOURNEY GUIDE WIRE WAS PLACED ACROSS THE LESION AND THE 2MM X 40MM STERLING BALLOON CATHETER WAS ADVANCED FOR PRE-DILATION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 2ATMS AND A LEAK WAS NOTED. THE DEVICE WAS EXCHANGED FOR A 2.5MM X 40MM STERLING BALLOON WHICH WAS INFLATED THREE TIMES. A 2.0MM X 15MM SPCB FLEXTOME CATHETER WAS THEN INSERTED AND DIFFICULTY WAS REPORTED WHILE ADVANCING TO THE LESION. DURING THE FIRST INFLATION, THE SPCB RUPTURED AT 2ATMS. ADDITIONAL DILATIONS WERE PERFORMED WITH THE 2.5MM X 40MM STERLING BALLOON AND ANOTHER 2.0 SPCB TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STERLING ES PTA BALLOON DILATATION CATHETER | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | BOSTON SCIENTIFIC - MAPLE GROVE | H74939135204010 | 13990908 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6FR 10CM MEDIKIT INTRODUCER SHEATH| 2.0MM/1.5CM SPCB FLEXTOME CATHETER| 014/185CM JOURNEY GUIDE WIRE| ENCORE 26 INFLATION DEVICE |