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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name and address: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via ipsilateral retrograde approach.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified common iliac artery.After a guidewire was crossed the lesion, an 8.0 x 20, 75cm mustang balloon catheter was advanced for dilation.However, during inflation at 14 atmospheres for 30 seconds, the balloon ruptured.The device was removed and replaced with another 8.0 x 20, 75cm mustang balloon catheter which also ruptured during first inflation at 14 atmospheres for 30 seconds.The device was removed from the patient.The procedure was completed with a 7mm mustang balloon catheter and placement of a non-bsc device.There were no patient complications nor injuries reported.The patient condition was good.

• 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: 12194613
• Report Number: 2134265-2021-09254
• Device Sequence Number: 3441377
• Product Code: FGE
• UDI-Device Identifier: 08714729793519
• UDI-Public: 08714729793519
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/20/2021

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: 07/15/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0025721987
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1