MUSTANG?
Report
- Report Number
- 2124215-2025-25332
- Event Type
- Malfunction
- Date Received
- April 22, 2025
- Date of Event
- March 20, 2025
- Report Date
- June 17, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- PMA / PMN Number
- K103751
- 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). G4 - PREMARKET / 510(K): K103751, K110122, K141521.
D2B - PRO CODE (PRODUCT CODE): FGE, LIT. E1 - INITIAL REPORTER FACILITY NAME: (B)(6). G4 - PREMARKET / 510(K): K103751, K110122, K141521.
D2B - PRO CODE (PRODUCT CODE): FGE, LIT. E1 - INITIAL REPORTER FACILITY NAME: (B)(6). G4 - PREMARKET / 510(K): K103751, K110122, K141521. DEVICE EVALUATED BY MFR: THE MUSTANG 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 PER MUSTANG SPECIFICATION (#90519237). THE RETURNED DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT. THE BALLOON WAS INFLATED TO ITS RATED BURST PRESSURE OF 18 ATMOSPHERES WITH NO LEAKS OR ISSUES NOTED WITH THE BALLOON MATERIAL. 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.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 7.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION, THE BALLOON BURST. 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 ARTERIOVENOUS FISTULA. A 7.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION, THE BALLOON BURST. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE OVER 80% TARGET LESION WAS LOCATED IN THE MILD CALCIFIED ARTERY, THE BALLOON WAS RUPTURED UPON FIRST INFLATION AT 5 ATMOSPHERES FOR 3 SECONDS. THE DEVICE WAS REMOVED NORMALLY.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 7.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION, THE BALLOON BURST. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE OVER 80% TARGET LESION WAS LOCATED IN THE MILD CALCIFIED ARTERY, THE BALLOON WAS RUPTURED UPON FIRST INFLATION AT 5 ATMOSPHERES FOR 3 SECONDS. THE DEVICE WAS REMOVED NORMALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1339310 | MUSTANG? | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74939171071510 | 0034833296 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Unknown |