MUSTANG?
Report
- Report Number
- 2124215-2025-43068
- Event Type
- Malfunction
- Date Received
- July 2, 2025
- Date of Event
- June 10, 2025
- Report Date
- September 22, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- PMA / PMN Number
- K141521
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B5. DESCRIBE EVENT OR PROBLEM: ADDED INFORMATION, BASED ON ADDITIONAL INFORMATION. D2B - PRO CODE (PRODUCT CODE): FGE, LIT. G4 - PREMARKET / 510(K) #: K141521, K141597.
D2B - PRO CODE (PRODUCT CODE): FGE, LIT G4 - PREMARKET / 510(K) #: K141521, K141597 GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
B5. DESCRIBE EVENT OR PROBLEM: ADDED INFORMATION, BASED ON ADDITIONAL INFORMATION D2B - PRO CODE (PRODUCT CODE): FGE, LIT G4 - PREMARKET / 510(K) #: K141521, K141597 DEVICE EVALUATED BY MFR: THE MUSTANG DEVICE WAS RETURNED TO OUR POST MARKET QUALITY ASSURANCE LABORATORY. THE DEVICE WAS RECEIVED WITH THE BALLOON PROTECTOR STILL ON THE DEVICE. A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON WAS NEATLY FOLDED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. A LEAK TEST WAS CARRIED OUT AND THE BALLOON WAS INFLATED TO ITS RATED BURST PRESSURE FOR 30 SECONDS USING DEIONIZED WATER AND DIGITAL TIMER WITH NO LEAKS OR ANY ISSUES NOTED. A VACUUM WAS THEN APPLIED. THE INFLATION DEVICE WAS VERIFIED AT 24 ATMOSPHERES, BEFORE AND AFTER USE WITH CALIBRATED PRESSURE GAUGE. THIS INFLATION TO RATE OF BURST PRESSURE WAS REPEATED THREE TIMES WITH NO LEAKS OR DROP IN PRESSURE NOTED. NO ISSUES WERE IDENTIFIED WITH BALLOON INFLATION OR THE BALLOON MATERIAL. AS PER HUB, THE RATED BURST PRESSURE FOR THIS DEVICE IS 24 ATMOSPHERES. NO ISSUES WERE NOTED WITH THE TIP OF THE DEVICE. A VISUAL EXAMINATION FOUND NO ISSUE WITH THE MARKERBANDS. A VISUAL AND TACTILE EXAMINATION FOUND NO KINKS OR DAMAGE TO THE SHAFT OF THE DEVICE. THIS CONCLUDES THE PRODUCT ANALYSIS.
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 5.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON RUPTURED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ARTERIOVENOUS FISTULA. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 5.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON RUPTURED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 5.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON RUPTURED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ARTERIOVENOUS FISTULA. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1142205 | MUSTANG? | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74939171050870 | 0035762973 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |