CHARGER
Report
- Report Number
- 2124215-2025-17970
- Event Type
- Malfunction
- Date Received
- March 25, 2025
- Date of Event
- February 26, 2025
- Report Date
- June 27, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729803799
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D2B: PRO CODE (PRODUCT CODE): FGE, LIT. G4: PREMARKET / 510(K) #: K112697, K112701, K141521. DEVICE EVALUATED BY MFR: THE CHARGER 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 14 ATMOSPHERES AS CHARGER SPECIFICATION (B)(4). THE RETURNED DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT. POSITIVE PRESSURE WAS APPLIED WHEN LIQUID WAS OBSERVED TO BE LEAKING FROM A BALLOON PINHOLE LOCATED APPROXIMATELY 6MM DISTAL FROM THE PROXIMAL MARKERBAND. INFLATION OF THE DEVICE IS NOT POSSIBLE DUE TO THE BALLOON PINHOLE. A VISUAL EXAMINATION OF THE MARKERBANDS IDENTIFIED NO ISSUES. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO KINKS OR DAMAGE TO THE SHAFT. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO DAMAGE TO THE TIP OF THE DEVICE.
D2B: PRO CODE (PRODUCT CODE): FGE, LIT. G4: PREMARKET / 510(K) #: K112697, K112701, K141521.
IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE TARGET LESION WAS SITUATED IN THE PERIPHERAL ARTERY. A 10.0 X 40 MM, 75 CM CHARGER BALLOON CATHETER WAS SELECTED FOR DILATION. THE PROCEDURE COMMENCED WITH A SUCCESSFUL ANGIOGRAPHY PERFORMED VIA A 6 FRENCH SHEATH, AND THE LESION WAS SUCCESSFULLY CROSSED WITH A GUIDEWIRE. ADDITIONALLY, INTRAVASCULAR ULTRASOUND (IVUS) WAS EFFECTIVELY CONDUCTED TO FURTHER ASSESS THE LESION. HOWEVER, DURING THE PREPARATION FOR BALLOON DILATION, A LEAK WAS DETECTED AT THE BALLOON PACKAGE OPENING. THIS ISSUE LED TO THE BALLOON RUPTURING UPON THE FIRST INFLATION ATTEMPT. CONSEQUENTLY, THE PLANNED DILATION COULD NOT BE COMPLETED WITH THE INITIAL DEVICE. THE PROCEDURE WAS SUBSEQUENTLY ADAPTED, AND AN ALTERNATIVE DEVICE WAS UTILIZED TO ACHIEVE THE DESIRED OUTCOME. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE TARGET LESION WAS SITUATED IN THE PERIPHERAL ARTERY. A 10.0 X 40 MM, 75 CM CHARGER BALLOON CATHETER WAS SELECTED FOR DILATION. THE PROCEDURE COMMENCED WITH A SUCCESSFUL ANGIOGRAPHY PERFORMED VIA A 6 FRENCH SHEATH, AND THE LESION WAS SUCCESSFULLY CROSSED WITH A GUIDEWIRE. ADDITIONALLY, INTRAVASCULAR ULTRASOUND (IVUS) WAS EFFECTIVELY CONDUCTED TO FURTHER ASSESS THE LESION. HOWEVER, DURING THE PREPARATION FOR BALLOON DILATION, A LEAK WAS DETECTED AT THE BALLOON PACKAGE OPENING. THIS ISSUE LED TO THE BALLOON RUPTURING UPON THE FIRST INFLATION ATTEMPT. CONSEQUENTLY, THE PLANNED DILATION COULD NOT BE COMPLETED WITH THE INITIAL DEVICE. THE PROCEDURE WAS SUBSEQUENTLY ADAPTED, AND AN ALTERNATIVE DEVICE WAS UTILIZED TO ACHIEVE THE DESIRED OUTCOME. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1133113 | CHARGER | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74939206100470 | 0033063854 | 08714729803799 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Male |