CHARGER?
Report
- Report Number
- 2124215-2025-60649
- Event Type
- Malfunction
- Date Received
- August 28, 2025
- Date of Event
- August 1, 2025
- Report Date
- March 25, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729804536
- PMA / PMN Number
- K112697
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
UPDATED A1: PATIENT IDENTIFIER D2B - PRO CODE (PRODUCT CODE): FGE, LIT. E1 - INITIAL REPORTER FACILITY NAME: (B)(6). E1 - INITIAL REPORTER ADDRESS 1: (B)(6). E1 - INITIAL REPORTER PHONE: (B)(6). G4 - PREMARKET / 510(K) #: K112697, K112701, K141521. DEVICE EVALUATED BY MFR: THE CHARGER DEVICE WAS RETURNED TO OUR POST MARKET QUALITY ASSURANCE LABORATORY. A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON WAS NOT FOLDED WHICH INDICATES THAT THE BALLOON WAS SUBJECTED TO POSITIVE PRESSURE. A LONGITUDINAL TEAR WAS IDENTIFIED IN THE BALLOON MATERIAL. THE TEAR MEASURED 35MM IN LENGTH AND EXTENDED FROM A POSITION 9MM DISTAL OF THE PROXIMAL MARKERBAND TO 6MM DISTAL OF THE DISTAL MARKERBAND. A VISUAL EXAMINATION OBSERVED NO DAMAGE TO THE TIP OF THE DEVICE. A VISUAL AND TACTILE EXAMINATION OF THE SHAFT OF THE DEVICE FOUND NO ISSUES. A VISUAL EXAMINATION FOUND NO ISSUES OR DAMAGE TO THE MARKERBANDS OF THE DEVICE. THIS CONCLUDES THE PRODUCT ANALYSIS.
D2B - PRO CODE (PRODUCT CODE): FGE, LIT. E1 - INITIAL REPORTER FACILITY NAME: (B)(6). E1 - INITIAL REPORTER ADDRESS 1: (B)(6). E1 - INITIAL REPORTER PHONE: (B)(6). G4 - PREMARKET / 510(K) #: K112697, K112701, K141521.
D2B - PRO CODE (PRODUCT CODE): FGE, LIT. E1 - INITIAL REPORTER FACILITY NAME: (B)(6). G4 - PREMARKET / 510(K) #: K112697, K112701, K141521. DEVICE EVALUATED BY MFR: THE CHARGER DEVICE WAS RETURNED TO OUR POST MARKET QUALITY ASSURANCE LABORATORY. A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON WAS NOT FOLDED WHICH INDICATES THAT THE BALLOON WAS SUBJECTED TO POSITIVE PRESSURE. A LONGITUDINAL TEAR WAS IDENTIFIED IN THE BALLOON MATERIAL. THE TEAR MEASURED 35MM IN LENGTH AND EXTENDED FROM A POSITION 9MM DISTAL OF THE PROXIMAL MARKERBAND TO 6MM DISTAL OF THE DISTAL MARKERBAND. A VISUAL EXAMINATION OBSERVED NO DAMAGE TO THE TIP OF THE DEVICE. A VISUAL AND TACTILE EXAMINATION OF THE SHAFT OF THE DEVICE FOUND NO ISSUES. A VISUAL EXAMINATION FOUND NO ISSUES OR DAMAGE TO THE MARKERBANDS OF THE DEVICE. THIS CONCLUDES THE PRODUCT ANALYSIS.
D2B - PRO CODE (PRODUCT CODE): FGE, LIT E1 - INITIAL REPORTER FACILITY NAME: (B)(6). E1 - INITIAL REPORTER ADDRESS 1: (B)(6). E1 - INITIAL REPORTER PHONE: (B)(6). G4 - PREMARKET / 510(K) #: K112697, K112701, K141521.
IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS ARTIFICIAL ARTERIOVENOUS FISTULA BALLOON DILATATION IN THE LEFT FOREARM AND INTRAVENOUS THROMBOLYSIS IN THE UPPER LIMB UNDER LOCAL ANESTHESIA WITH B-ULTRASOUND POSITIONING. A 7.0 X40, 75CM CHARGER BALLOON WAS PUNCTURED SUCCESSFULLY UNDER THE GUIDANCE OF B ULTRASOUND. HOWEVER, BALLOON BURST BEFORE REACHING THE BURSTING PRESSURE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED AFTER THE PRESSURE PUMP RELEASED PRESSURE DURING THE FIRST INFLATION AT 12 ATMOSPHERES FOR 15 SECONDS. DEVICE EVALUATED BY MFR: THE CHARGER DEVICE WAS RETURNED TO OUR POST MARKET QUALITY ASSURANCE LABORATORY. A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON WAS NOT FOLDED WHICH INDICATES THAT THE BALLOON WAS SUBJECTED TO POSITIVE PRESSURE. A LONGITUDINAL TEAR WAS IDENTIFIED IN THE BALLOON MATERIAL. THE TEAR MEASURED 35MM IN LENGTH AND EXTENDED FROM A POSITION 9MM DISTAL OF THE PROXIMAL MARKERBAND TO 6MM DISTAL OF THE DISTAL MARKERBAND. A VISUAL EXAMINATION OBSERVED NO DAMAGE TO THE TIP OF THE DEVICE. A VISUAL AND TACTILE EXAMINATION OF THE SHAFT OF THE DEVICE FOUND NO ISSUES. A VISUAL EXAMINATION FOUND NO ISSUES OR DAMAGE TO THE MARKERBANDS OF THE DEVICE. THIS CONCLUDES THE PRODUCT ANALYSIS. IT WAS FURTHER REPORTED THAT THE PATIENT DID NOT HAVE CHALLENGING ANATOMY AND THE PROCEDURAL FACTORS DID NOT CONTRIBUTE TO THE EVENT.
IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS ARTIFICIAL ARTERIOVENOUS FISTULA BALLOON DILATATION IN THE LEFT FOREARM AND INTRAVENOUS THROMBOLYSIS IN THE UPPER LIMB UNDER LOCAL ANESTHESIA WITH B-ULTRASOUND POSITIONING. A 7.0 X40, 75CM CHARGER BALLOON WAS PUNCTURED SUCCESSFULLY UNDER THE GUIDANCE OF B ULTRASOUND. HOWEVER, BALLOON BURST BEFORE REACHING THE BURSTING PRESSURE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.
IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS ARTIFICIAL ARTERIOVENOUS FISTULA BALLOON DILATATION IN THE LEFT FOREARM AND INTRAVENOUS THROMBOLYSIS IN THE UPPER LIMB UNDER LOCAL ANESTHESIA WITH B-ULTRASOUND POSITIONING. A 7.0 X40, 75CM CHARGER BALLOON WAS PUNCTURED SUCCESSFULLY UNDER THE GUIDANCE OF B ULTRASOUND. HOWEVER, BALLOON BURST BEFORE REACHING THE BURSTING PRESSURE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED AFTER THE PRESSURE PUMP RELEASED PRESSURE DURING THE FIRST INFLATION AT 12 ATMOSPHERES FOR 15 SECONDS.
IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS ARTIFICIAL ARTERIOVENOUS FISTULA BALLOON DILATATION IN THE LEFT FOREARM AND INTRAVENOUS THROMBOLYSIS IN THE UPPER LIMB UNDER LOCAL ANESTHESIA WITH B-ULTRASOUND POSITIONING. A 7.0 X40, 75CM CHARGER BALLOON WAS PUNCTURED SUCCESSFULLY UNDER THE GUIDANCE OF B ULTRASOUND. HOWEVER, BALLOON BURST BEFORE REACHING THE BURSTING PRESSURE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED AFTER THE PRESSURE PUMP RELEASED PRESSURE DURING THE FIRST INFLATION AT 12 ATMOSPHERES FOR 15 SECONDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 341192 | CHARGER? | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74939206070470 | 0032264531 | 08714729804536 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male |