MUSTANG?
Report
- Report Number
- 2124215-2025-26698
- Event Type
- Malfunction
- Date Received
- April 28, 2025
- Date of Event
- March 22, 2025
- Report Date
- June 18, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LIT
- UDI-DI
- 08714729793557
- PMA / PMN Number
- K110122
- 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): K103751, K110122. THE DEVICE WAS RETURNED FOR ANALYSIS. UPON VISUAL INSPECTION, IT WAS DETERMINED THAT THE BALLOON WAS NOT FOLDED, INDICATING THAT IT HAD BEEN SUBJECTED TO POSITIVE PRESSURE. A BALLOON PINHOLE WAS IDENTIFIED IN THE BALLOON MATERIAL AT THE PROXIMAL MARKERBAND. ACCORDING TO THE SPECIFICATIONS, THE RATED BURST PRESSURE FOR THIS DEVICE IS 24 ATMOSPHERES. A VISUAL AND TACTILE EXAMINATION OF THE SHAFT REVEALED NO KINKS OR DAMAGE, AND A SIMILAR INSPECTION OF THE TIP FOUND NO DAMAGE AS WELL. ADDITIONALLY, A VISUAL ASSESSMENT OF THE MARKERBANDS CONFIRMED THAT BOTH WERE UNDAMAGED AND CORRECTLY POSITIONED ON THE DEVICE.
D2B - PRO CODE (PRODUCT CODE): FGE, LIT. G4 - PREMARKET / 510(K): K103751, K110122. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE DEVICE STATUS, BUT IT WAS UNABLE TO BE OBTAINED. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
D2B - PRO CODE (PRODUCT CODE): FGE, LIT. G4 - PREMARKET / 510(K): K103751, K110122.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 4.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION ALONG WITH THE GUIDEWIRE. DURING INFLATION AT 20 ATMOSPHERES, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LESION.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 4.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION ALONG WITH THE GUIDEWIRE. DURING INFLATION AT 20 ATMOSPHERES, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 4.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION ALONG WITH THE GUIDEWIRE. DURING INFLATION AT 20 ATMOSPHERES, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LESION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1237364 | MUSTANG? | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | LIT | BOSTON SCIENTIFIC CORPORATION | H74939171040410 | 0034790958 | 08714729793557 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Male |