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	11/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the popliteal vein.A 10.0 x 60, 135cm mustang balloon catheter was advanced for dilatation.However, during inflation, half of it was inside of a wallstent, the other half of it was in the iliac vein and the balloon burst at 8 atmospheres.The device was removed from the patient's body.Another 10.0 x 60, 135cm mustang balloon catheter was inserted into the patient.However, during inflation, half of it was inside of a wallstent, the other half was in the iliac and it also burst at 8 atmospheres.When the device was removed, the shaft of the balloon broke off of the proximal part of the balloon.They had to remove the 8f non-bsc sheath to get the balloon and the rest of the shaft out of the popliteal vein.They were able to retrieve everything out of the patient's body.Insert a new sheath and the procedure was completed with a different device.No patient complications were reported and the patient was fine.

• 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: 9410224
• Report Number: 2134265-2019-14524
• Device Sequence Number: 4114611
• Product Code: FGE
• UDI-Device Identifier: 08714729795230
• UDI-Public: 08714729795230
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K141521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2019

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 Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0024235952
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR