CHARGER?
Report
- Report Number
- 2124215-2026-05890
- Event Type
- Malfunction
- Date Received
- February 2, 2026
- Date of Event
- December 29, 2025
- Report Date
- May 11, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729804666
- 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. E1: INITIAL REPORTER FACILITY NAME: (B)(6). E1: INITIAL REPORTER PHONE: (B)(6). G4: PREMARKET / 510(K): K112697, K112701, K141521. INVESTIGATION RESULTS: DEVICE ANALYSIS FINDINGS: UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS CHARGER DEVICE WAS EXAMINED. A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON WAS NOT FOLDED WHICH INDICATES THAT THE BALLOON WAS SUBJECTED TO POSITIVE PRESSURE. THE RATED BURST PRESSURE FOR THIS DEVICE IS 18 ATMOSPHERES AS CHARGER. THE RETURNED DEVICE WAS ATTACHED TO AN INFLATION UNIT. POSITIVE PRESSURE WAS APPLIED WHEN LIQUID WAS OBSERVED TO BE LEAKING FROM A BALLOON PINHOLE LOCATED APPROXIMATELY 6MM PROXIMAL FROM THE DISTAL MARKERBAND, WHICH CONFIRMS THE EVENT. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. DHR (DEVICE HISTORY RECORD) REVIEW 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 BALLOON- MATERIAL RUPTURE WAS A KNOWN EVENT DEFINED IN THE PRODUCTS 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 CONCLUDES THE MOST PROBABLE ROOT CAUSE AS ADVERSE EVENT RELATED TO PROCEDURE.
D2B: PRO CODE: (PRODUCT CODE): FGE, LIT. E1: (B)(6). G4: PREMARKET / 510(K): K112697, K112701, K141521. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.
D2B: PRO CODE: (PRODUCT CODE): FGE, LIT. E1: (B)(6). G4: PREMARKET / 510(K): K112697, K112701, K141521. INVESTIGATION RESULTS: DEVICE EVALUATED BY MFR: THE 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. THE RATED BURST PRESSURE FOR THIS DEVICE IS 18 ATMOSPHERES AS CHARGER. THE RETURNED DEVICE WAS ATTACHED TO AN INFLATION UNIT. POSITIVE PRESSURE WAS APPLIED WHEN LIQUID WAS OBSERVED TO BE LEAKING FROM A BALLOON PINHOLE LOCATED APPROXIMATELY 6MM PROXIMAL FROM THE DISTAL MARKERBAND, WHICH CONFIRMS THE EVENT. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. DHR (DEVICE HISTORY RECORD) REVIEW: 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. RISK REVIEW: A RISK REVIEW PERFORMED FOR THE CHARGER DEVICE CONFIRMED THAT THE EVENT OF BALLOON- MATERIAL RUPTURE WAS A KNOWN EVENT DEFINED IN THE PRODUCTS 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 CONCLUDES THE MOST PROBABLE ROOT CAUSE AS ADVERSE EVENT RELATED TO PROCEDURE.
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT THORACIC ENDOVASCULAR AORTIC REPAIR UNDER GENERAL ANESTHESIA. VASCULAR ACCESS WAS OBTAINED UNDER B-ULTRASOUND GUIDANCE, AND AN 8.0 X 40, 135 CM CHARGER BALLOON CATHETER WAS ADVANCED TO PERFORM THE FENESTRATION PROCEDURE. DURING THE PROCEDURE, THE BALLOON RUPTURED BEFORE THE RATED BURST PRESSURE WAS REACHED. 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 PATIENT UNDERWENT THORACIC ENDOVASCULAR AORTIC REPAIR UNDER GENERAL ANESTHESIA. VASCULAR ACCESS WAS OBTAINED UNDER B-ULTRASOUND GUIDANCE, AND AN 8.0 X 40, 135 CM CHARGER BALLOON CATHETER WAS ADVANCED TO PERFORM THE FENESTRATION PROCEDURE. DURING THE PROCEDURE, THE BALLOON RUPTURED BEFORE THE RATED BURST PRESSURE WAS REACHED. 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 PATIENT UNDERWENT THORACIC ENDOVASCULAR AORTIC REPAIR UNDER GENERAL ANESTHESIA. VASCULAR ACCESS WAS OBTAINED UNDER B-ULTRASOUND GUIDANCE, AND AN 8.0 X 40, 135 CM CHARGER BALLOON CATHETER WAS ADVANCED TO PERFORM THE FENESTRATION PROCEDURE. DURING THE PROCEDURE, THE BALLOON RUPTURED BEFORE THE RATED BURST PRESSURE WAS REACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 80771 | CHARGER? | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74939206080410 | 0036600191 | 08714729804666 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |