CHARGER?
Report
- Report Number
- 2124215-2025-83366
- Event Type
- Malfunction
- Date Received
- November 17, 2025
- Date of Event
- October 24, 2025
- Report Date
- January 20, 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
D2B: PRO CODE: (PRODUCT CODE): FGE, LIT. G4: PREMARKET/510(K): K112697, K112701, K141521. E1: INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. E1: INITIAL REPORTER PHONE: (B)(6).
A2 - AGE AT TIME OF EVENT: 18 YEARS OR OLDER. B5 - DESCRIBE EVENT OR PROBLEM: UPDATED TO INCLUDE NEW INFORMATION OBTAINED. D2B: PRO CODE: (PRODUCT CODE): FGE, LIT. G4: PREMARKET / 510(K): K112697, K112701, K141521. E1: INITIAL REPORTER FACILITY NAME: (B)(6). E1: INITIAL REPORTER PHONE: (B)(6). A CHARGER 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 PINHOLE WAS IDENTIFIED, CONFIRMING THE EVENT. NO ISSUES WERE NOTED WITH THE TIP OR MARKERBANDS OF THE DEVICE AND NO KINKS OR DAMAGE WAS NOTED ALONG THE SHAFT OF THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.
A2 - AGE AT TIME OF EVENT: 18 YEARS OR OLDER. B5 - DESCRIBE EVENT OR PROBLEM: UPDATED TO INCLUDE NEW INFORMATION OBTAINED. D2B: PRO CODE: (PRODUCT CODE): FGE, LIT G4: PREMARKET / 510(K): K112697, K112701, K141521 E1: INITIAL REPORTER FACILITY NAME: (B)(6). E1: INITIAL REPORTER PHONE: (B)(6).
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS, MODERATELY CALCIFIED BRACHIAL ARTERY. A 7.0 X 40 MM, 75 CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AND LEAKED FLUID. THE RUPTURE POINT WAS NOTED AT APPROXIMATELY 2 CM. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS, MODERATELY CALCIFIED BRACHIAL ARTERY. A 7.0 X 40 MM, 75 CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AND LEAKED FLUID. THE RUPTURE POINT WAS NOTED AT APPROXIMATELY 2 CM. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT DURING THE INITIAL INFLATION AT 10 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED.
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS, MODERATELY CALCIFIED BRACHIAL ARTERY. A 7.0 X 40 MM, 75 CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AND LEAKED FLUID. THE RUPTURE POINT WAS NOTED AT APPROXIMATELY 2 CM. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT DURING THE INITIAL INFLATION AT 10 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 289230 | CHARGER? | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74939206070470 | 0033946878 | 08714729804536 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |