MUSTANG?
Report
- Report Number
- 2124215-2025-76768
- Event Type
- Malfunction
- Date Received
- November 3, 2025
- Date of Event
- October 9, 2025
- Report Date
- January 8, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729793564
- PMA / PMN Number
- K141521
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D2B: PRO CODE: (PRODUCT CODE): FGE, LIT. G4: PREMARKET / 510(K): K141521, K141597. A MUSTANG DEVICE WAS RECEIVED FOR ANALYSIS. THE DEVICE WAS RECEIVED WITH THE BALLOON PROTECTOR STILL ON THE BALLOON. THE INVESTIGATOR REMOVED THE BALLOON PROTECTOR. THE BALLOON WAS TIGHTLY FOLDED AND WAS NOT SUBJECT TO POSITIVE PRESSURE. 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.
D2B: PRO CODE: (PRODUCT CODE): FGE, LIT. G4: PREMARKET / 510(K): K141521, K141597. H6 - DEVICE CODES: CORRECTED.
D2B: PRO CODE: (PRODUCT CODE): FGE, LIT. G4: PREMARKET / 510(K): K141521, K141597.
IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED VESSEL. A 6.0 X 40, 40CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. UPON UNPACKING THE STERILE POUCH AND TAKING THE HOOP OUT, IT WAS OBSERVED THAT THE BALLOON WAS NOT SECURELY ATTACHED TO THE HOOP, RESULTING IN BALLOON DETACHMENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED VESSEL. A 6.0 X 40, 40CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. UPON UNPACKING THE STERILE POUCH AND TAKING THE HOOP OUT, IT WAS OBSERVED THAT THE BALLOON WAS NOT SECURELY ATTACHED TO THE HOOP, RESULTING IN BALLOON DETACHMENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT UPON UNPACKING THE STERILE POUCH AND TAKING THE HOOP OUT, THE BALLOON WAS NOT SECURELY ATTACHED TO THE HOOP, THE ENTIRE BALLOON CATHETER SLIPPED OUT OF THE PROTECTIVE HOOP.
IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED VESSEL. A 6.0 X 40, 40CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. UPON UNPACKING THE STERILE POUCH AND TAKING THE HOOP OUT, IT WAS OBSERVED THAT THE BALLOON WAS NOT SECURELY ATTACHED TO THE HOOP, RESULTING IN BALLOON DETACHMENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1709844 | MUSTANG? | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74939171060440 | 0035445768 | 08714729793564 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |