WANDA PTA BALLOON DILATATION CATHETER
Report
- Report Number
- 2134265-2010-03188
- Event Type
- Malfunction
- Date Received
- July 27, 2010
- Date of Event
- June 29, 2010
- Report Date
- June 29, 2010
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- LIT
- PMA / PMN Number
- SIMILAR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE EVALUATED BY MANUFACTURER: VISUAL AND TACTILE EXAMINATION OF THE RETURNED DEVICE REVEALED THE BALLOON HAD COMPLETELY DETACHED DISTAL TO THE EDGE OF THE PROXIMAL BALLOON SLEEVE. A COMPLETE BREAK HAD OCCURRED IN THE SHAFT DISTAL TO THE STRAIN RELIEF. THE DISTAL TIP WAS STRETCHED AND THE ACTUAL TIP OF THE DEVICE ALONG WITH THE DISTAL RADIOPAQUE MARKER HAD ALSO DETACHED. THE ACTUAL TIP AND THE DISTAL SECTION OF THE BALLOON WERE NOT RETURNED. THE DISTAL RADIOPAQUE MARKER AND 2MM OF THE SHAFT MATERIAL ON EITHER SIDE OF THE RADIOPAQUE MARKER WAS RECEIVED. VISUAL AND MICROSCOPIC EXAMINATION OF THE SHAFT DISTAL TO THE PROXIMAL RADIOPAQUE MARKERBAND NOTED THAT IT WAS FLATTENED AND DAMAGED. NO OTHER DAMAGE WAS NOTED TO THE SHAFT OF THE DEVICE. THE DAMAGE NOTED IS CONSISTENT WITH THE DEVICE COMING IN CONTACT WITH A RESTRICTION AND THEN THE DEVICE BEEN PULLED ON DURING REMOVAL FROM THE SHEATH. 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).
DEVICE EVALUATED BY MANUFACTURER: VISUAL AND TACTILE EXAMINATION OF THE RETURNED DEVICE REVEALED THE BALLOON HAD COMPLETELY DETACHED DISTAL TO THE EDGE OF THE PROXIMAL BALLOON SLEEVE. A COMPLETE BREAK HAD OCCURRED IN THE SHAFT DISTAL TO THE STRAIN RELIEF. THE DISTAL TIP WAS STRETCHED AND THE ACTUAL TIP OF THE DEVICE ALONG WITH THE DISTAL RADIOPAQUE MARKER HAD ALSO DETACHED. THE ACTUAL TIP AND THE DISTAL SECTION OF THE BALLOON WERE NOT RETURNED. THE DISTAL RADIOPAQUE MARKER AND 2MM OF THE SHAFT MATERIAL ON EITHER SIDE OF THE RADIOPAQUE MARKER WAS RECEIVED. VISUAL AND MICROSCOPIC EXAMINATION OF THE SHAFT DISTAL TO THE PROXIMAL RADIOPAQUE MARKERBAND NOTED THAT IT WAS FLATTENED AND DAMAGED. NO OTHER DAMAGE WAS NOTED TO THE SHAFT OF THE DEVICE. THE DAMAGE NOTED IS CONSISTENT WITH THE DEVICE COMING IN CONTACT WITH A RESTRICTION AND THEN THE DEVICE BEEN PULLED ON DURING REMOVAL FROM THE SHEATH. 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).
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
THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WANDA PTA BALLOON DILATATION CATHETER | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | BOSTON SCIENTIFIC - GALWAY | H965SCH505160 | 13167109 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6FR TERUMO INTRODUCER SHEATH |