CHARGER?
Report
- Report Number
- 2124215-2025-54343
- Event Type
- Malfunction
- Date Received
- August 6, 2025
- Date of Event
- July 14, 2025
- Report Date
- November 4, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729804116
- 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.
D2B: PRO CODE (PRODUCT CODE): FGE, LIT. G4: PREMARKET / 510(K) #: K112697, K112701. (B)(6). DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR EVALUATION. 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 22MM IN LENGTH AND EXTENDED FROM A POSITION 2MM DISTAL OF THE PROXIMAL MARKERBAND TO 24MM DISTAL OF THE PROXIMAL 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. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.
D2B: PRO CODE (PRODUCT CODE): FGE, LIT. G4: PREMARKET / 510(K) #: K112697, K112701. E1 - INITIAL REPORTER PHONE:(B)(6).
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT UPPER LIMB. A 4.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS PRESSURIZED TO 20 ATMOSPHERES AND THE PRESSURE WAS REMOVED. THE BALLOON CONTINUED TO ENTER AND WAS INFLATED. IT WAS OBSERVED THAT THE PRESSURE PUMP VALUE DID NOT RISE, AND THE CONTRAST MEDIUM FLOWED BACK WITH THE BLOOD FLOW. THE BALLOON WAS JUDGED TO BE RUPTURED, THE BALLOON WAS WITHDRAWN, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT UPPER LIMB. A 4.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS PRESSURIZED TO 20 ATMOSPHERES, AND THE PRESSURE WAS REMOVED. THE BALLOON CONTINUED TO ENTER AND WAS INFLATED. IT WAS OBSERVED THAT THE PRESSURE PUMP VALUE DID NOT RISE, AND THE CONTRAST MEDIUM FLOWED BACK WITH THE BLOOD FLOW. THE BALLOON WAS JUDGED TO BE RUPTURED, THE BALLOON WAS WITHDRAWN, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE 67% STENOSED TARGET LESION WAS LOCATED IN THE RADIAL ARTERY TO BASILIC VEIN ARTERIOVENOUS FISTULA ANASTOMOSIS SITE AND THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM USING THE NORMAL METHOD.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT UPPER LIMB. A 4.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS PRESSURIZED TO 20 ATMOSPHERES AND THE PRESSURE WAS REMOVED. THE BALLOON CONTINUED TO ENTER AND WAS INFLATED. IT WAS OBSERVED THAT THE PRESSURE PUMP VALUE DID NOT RISE, AND THE CONTRAST MEDIUM FLOWED BACK WITH THE BLOOD FLOW. THE BALLOON WAS JUDGED TO BE RUPTURED, THE BALLOON WAS WITHDRAWN, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE 67 % STENOSED TARGET LESION WAS LOCATED IN THE RADIAL ARTERY TO BASILIC VEIN ARTERIOVENOUS FISTULA ANASTOMOSIS SITE AND THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM USING THE NORMAL METHOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1528616 | CHARGER? | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74939206040470 | 0033576885 | 08714729804116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female |