CHARGER?
Report
- Report Number
- 2124215-2025-86792
- Event Type
- Malfunction
- Date Received
- December 10, 2025
- Date of Event
- November 17, 2025
- Report Date
- April 2, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729804673
- PMA / PMN Number
- K112697
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A2 - AGE AT TIME OF EVENT: 18 YEARS OR OLDER. G4: PREMARKET / 510(K): K112697, K112701, K141521. E1: INITIAL REPORTER PHONE: (B)(6).
A2 - AGE AT TIME OF EVENT: 18 YEARS OR OLDER. G4: PREMARKET / 510(K): K112697, K112701, K141521. E1: INITIAL REPORTER PHONE: (B)(6). INVESTIGATION RESULTS: DEVICE ANALYSIS FINDINGS: THE DEVICE WAS RETURNED LOADED ON TO THE CUSTOMERS GUIDEWIRE. A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON HAD BEEN SUBJECTED TO POSITIVE PRESSURE. NO DAMAGE OR ISSUES WERE FOUND WITH THE BALLOON, SHAFT, TIP, OR MARKERBANDS OF THE DEVICE. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE CUSTOMERS GUIDEWIRE WITHOUT ISSUE. NO ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. DEVICE HISTORY RECORD: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THAT THE CONTENT WAS SUFFICIENT AND DID NOT CONTRIBUTE TO THE REPORTED EVENT; THEREFORE, NO UPDATES ARE REQUIRED TO THE DOCUMENT AT THIS TIME. RISK REVIEW: A RISK REVIEW PERFORMED FOR THE CHARGER DEVICE CONFIRMED THAT THE EVENT OF ENTRAPMENT OF DEVICE WAS DEFINED IN THE PRODUCT'S RISK MANAGEMENT DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF NO PROBLEM DETECTED.
IT WAS REPORTED THAT THE DEVICE BECAME ENTRAPPED ON THE GUIDEWIRE. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED ILIAC VEIN. A NON-BOSTON SCIENTIFIC GUIDEWIRE WAS USED DURING THE PROCEDURE. AN 8.0 X 40 MM, 75 CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON CATHETER AND GUIDEWIRE BECAME STUCK TOGETHER AND COULD NOT BE WITHDRAWN. AS A RESULT, THE BALLOON CATHETER AND GUIDEWIRE HAD TO BE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.
IT WAS REPORTED THAT THE DEVICE BECAME ENTRAPPED ON THE GUIDEWIRE. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED ILIAC VEIN. A NON-BOSTON SCIENTIFIC GUIDEWIRE WAS USED DURING THE PROCEDURE. AN 8.0 X 40 MM, 75 CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON CATHETER AND GUIDEWIRE BECAME STUCK TOGETHER AND COULD NOT BE WITHDRAWN. AS A RESULT, THE BALLOON CATHETER AND GUIDEWIRE HAD TO BE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2115075 | CHARGER? | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74939206080470 | 0034890787 | 08714729804673 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | GUIDEWIRE: TERUMO |