MUSTANG?
Report
- Report Number
- 2124215-2025-83947
- Event Type
- Malfunction
- Date Received
- November 18, 2025
- Date of Event
- October 31, 2025
- Report Date
- February 11, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729793335
- PMA / PMN Number
- K141521
- 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): K141521, K141597. E1: INITIAL REPORTER PHONE: (B)(6). GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS AND DEVICE STATUS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.
B5 - DESCRIBE EVENT OR PROBLEM: UPDATED TO INCLUDE NEW INFORMATION OBTAINED. D2B: PRO CODE: (PRODUCT CODE): FGE, LIT. (B)(6). G4: PREMARKET / 510(K): K141521, K141597. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE DEVICE STATUS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.
D2B: PRO CODE: (PRODUCT CODE): FGE, LIT. (B)(6). G4: PREMARKET / 510(K): K141521, K141597. THE MUSTANG DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON HAD BEEN SUBJECTED TO POSITIVE PRESSURE. A PINHOLE IN THE BALLOON MATERIAL WAS IDENTIFIED CONFIRMING THE EVENT. NO DAMAGE OR ISSUES WERE FOUND WITH THE SHAFT, TIP OR MARKERBANDS OF THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARM. A 6.0 X 40 MM, 75 CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION OVER A 0.035-INCH LOACH GUIDEWIRE, AND THE PRESSURE PUMP WAS CONNECTED. WHEN THE PRESSURE REACHED 8 ATMOSPHERES, THE OPERATOR FELT THE BALLOON BEGIN TO DEFLATE, AND UPON REMOVAL FROM THE PATIENTS BODY, THE BALLOON WAS FOUND TO HAVE RUPTURED. A NEW 6.0 X 40 MM, 75 CM MUSTANG BALLOON WAS THEN USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENTS CONDITION REMAINED STABLE FOLLOWING THE PROCEDURE.
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARM. A 6.0 X 40 MM, 75 CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION OVER A 0.035-INCH LOACH GUIDEWIRE, AND THE PRESSURE PUMP WAS CONNECTED. WHEN THE PRESSURE REACHED 8 ATMOSPHERES, THE OPERATOR FELT THE BALLOON BEGIN TO DEFLATE, AND UPON REMOVAL FROM THE PATIENTS BODY, THE BALLOON WAS FOUND TO HAVE RUPTURED. A NEW 6.0 X 40 MM, 75 CM MUSTANG BALLOON WAS THEN USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENTS CONDITION REMAINED STABLE FOLLOWING THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE PATIENTS ANATOMY WAS CHALLENGING.
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARM. A 6.0 X 40 MM, 75 CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION OVER A 0.035-INCH LOACH GUIDEWIRE, AND THE PRESSURE PUMP WAS CONNECTED. WHEN THE PRESSURE REACHED 8 ATMOSPHERES, THE OPERATOR FELT THE BALLOON BEGIN TO DEFLATE, AND UPON REMOVAL FROM THE PATIENT'S BODY, THE BALLOON WAS FOUND TO HAVE RUPTURED. A NEW 6.0 X 40 MM, 75 CM MUSTANG BALLOON WAS THEN USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT'S CONDITION REMAINED STABLE FOLLOWING THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE PATIENT'S ANATOMY WAS CHALLENGING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1863679 | MUSTANG? | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74939171060470 | 0035387078 | 08714729793335 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Male |