EQUALIZER?
Report
- Report Number
- 2134265-2014-02738
- Event Type
- Malfunction
- Date Received
- May 21, 2014
- Date of Event
- April 16, 2014
- Report Date
- April 24, 2014
- Manufacturer
- BOSTON SCIENTIFIC - CORK
- Product Code
- DQY
- PMA / PMN Number
- K021721
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
(B)(4).
DEVICE EVALUATED BY MFR: THE COMPLAINT SAMPLE RETURNED MATCHED THE REPORTED LOT NUMBER. THE CATHETER SHAFT WAS INSPECTED FOR COSMETIC DEFECTS AND NONE WERE FOUND. THE BALLOON WAS FOUND TO BE BURST/RUPTURED NEAR THE PROXIMAL. BOTH PROXIMAL AND DISTAL BALLOON BONDS WERE EXAMINED AND FOUND TO MEET THE REQUIRED BOND LENGTH SPECIFICATION. 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 BALLOON RUPTURE OCCURRED. A 27/7/2/100 EQUALIZER¿ CATHETER BALLOON WAS SELECTED FOR USE AND ADVANCED TO TREAT THE TARGET LESION. INITIALLY, THE BALLOON WAS INFLATED AT AN UNSPECIFIED PRESSURE WITHOUT ANY ISSUE. UPON THE SECOND INFLATION, THE BALLOON RUPTURED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 27/7/2/100 EQUALIZER¿ CATHETER BALLOON WAS SELECTED FOR USE AND ADVANCED TO TREAT THE TARGET LESION. INITIALLY, THE BALLOON WAS INFLATED AT AN UNSPECIFIED PRESSURE WITHOUT ANY ISSUE. UPON THE SECOND INFLATION, THE BALLOON RUPTURED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303010 | EQUALIZER? | CATHETER, PERCUTANEOUS | DQY | BOSTON SCIENTIFIC - CORK | M001171080 | 0016735927 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |