CHARGER
Report
- Report Number
- 2124215-2024-77839
- Event Type
- Malfunction
- Date Received
- December 11, 2024
- Date of Event
- November 25, 2024
- Report Date
- January 9, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729804543
- PMA / PMN Number
- K112697
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D2B: PRODUCT CODE - LIT G4: PMA/510(K) # FIELD ON 3500A FORM - K112701, K141521.
D2B: PRODUCT CODE - LIT. G4: PMA/510(K) # FIELD ON 3500A FORM - K112701, K141521. DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON WAS NOT FOLDED WHICH INDICATES THAT THE BALLOON WAS SUBJECTED TO POSITIVE PRESSURE. A BALLOON LONGITUDINAL TEAR WAS IDENTIFIED BEGINNING APPROXIMATELY 20MM DISTAL OF THE PROXIMAL MARKERBAND AND EXTENDING DISTALLY ACROSS THE BALLOON MATERIAL TO THE DISTAL BALLOON SLEEVE. THE RATED BURST PRESSURE FOR THIS DEVICE IS 18 ATMOSPHERES. A VISUAL AND TACTILE EXAMINATION FOUND NO KINKS OR DAMAGE TO THE SHAFT OF THE DEVICE. A VISUAL AND TACTILE EXAMINATION FOUND NO DAMAGE TO THE TIP OF THE DEVICE. A VISUAL EXAMINATION OBSERVED NO ISSUES WITH THE MARKERBANDS OF THE DEVICE. BOTH MARKERBANDS WERE UNDAMAGED IN THE CORRECT POSITION ON THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE.
IT WAS REPORTED THAT THERE IS A HOLE IN THE BALLOON OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS BALLOON DILATION OF AN ARTIFICIAL ARTERIOVENOUS FISTULA IN THE LEFT FOREARM, ALONG WITH THROMBOLYSIS OF THE UPPER LIMB VEIN, PERFORMED UNDER LOCAL ANESTHESIA. A 7.0 X60, 75CM CHARGER BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED, AND IMAGING REVEALED ABNORMALITIES. UPON REMOVAL FROM THE PATIENT AND FLUSHING WITH HEPARINIZED SALINE, A VISIBLE DEFECT WAS IDENTIFIED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLAICATIONS REPORTED.
IT WAS REPORTED THAT THERE IS A HOLE IN THE BALLOON OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS BALLOON DILATION OF AN ARTIFICIAL ARTERIOVENOUS FISTULA IN THE LEFT FOREARM, ALONG WITH THROMBOLYSIS OF THE UPPER LIMB VEIN, PERFORMED UNDER LOCAL ANESTHESIA. A 7.0 X60, 75CM CHARGER BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED, AND IMAGING REVEALED ABNORMALITIES. UPON REMOVAL FROM THE PATIENT AND FLUSHING WITH HEPARINIZED SALINE, A VISIBLE DEFECT WAS IDENTIFIED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLAICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2442319 | CHARGER | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74939206070670 | 0030888608 | 08714729804543 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male |