MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG; CATHETER, BILIARY, DIAGNOSTIC

Model Number	24674
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occured.The stenosed target lesion was located in the popliteal and posterior tibial artery.A 4.0 x 60, 135cm mustang balloon catheter was prepared, flushed with saline and then advanced into the guidewire inside the popliteal.During inflation at 6 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No patient serious injury or adverse event was reported and the patient status was stable.
Additional Manufacturer Narrative
A visual examination of the returned device noted that the balloon was unfolded and inflation medium was noted within the balloon which indicates it had been subjected to positive pressure.The returned device was loaded onto a 0.035in guidewire and attached to an encore inflation unit.Positive pressure was applied and the balloon was successfully inflated to its rate of burst pressure of 24 atmospheres with no leaks or drops in pressure noted.The pressure was held for 30 seconds.The inflation device was verified at 24atm, before and after use with a calibrated pressure gauge.This inflation to rate of burst pressure of 24atm was repeated three times and with issues or drop in pressure noted.A visual and microscopic examination of the balloon material identified no issues that could have contributed to the complaint incident.No issues were noted with the tip or markerbands of the device that could have contributed to the complaint incident.A visual and tactile examination found that the shaft was free from any damage.No issues were noted with the shaft that could have contributed to the complaint incident.No issues were identified during product analysis.
Event or Problem Description
It was reported that balloon rupture occured.The stenosed target lesion was located in the popliteal and posterior tibial artery.A 4.0 x 60, 135cm mustang balloon catheter was prepared, flushed with saline and then advanced into the guidewire inside the popliteal.During inflation at 6 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No patient serious injury or adverse event was reported and the patient status was stable.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8449188
• Report Number: 2134265-2019-02939
• Device Sequence Number: 18939866
• Product Code: FGE
• UDI-Device Identifier: 08714729794257
• UDI-Public: 08714729794257
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K103751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/11/2021
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0022786481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 75