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	07/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery.A 6.0 x 100, 135cm mustang balloon catheter was advanced for dilatation.However, during initial inflation at 14 atmospheres for less than 30 seconds, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
D4 - lot number: updated to 26273477.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery.A 6.0 x 100, 135cm mustang balloon catheter was advanced for dilatation.However, during initial inflation at 14 atmospheres for less than 30 seconds, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported.

• 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: 12236634
• Report Number: 2134265-2021-09689
• Device Sequence Number: 14445671
• Product Code: FGE
• UDI-Device Identifier: 08714729793540
• UDI-Public: 08714729793540
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103751
• 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,Followup
• Report Date (Section B): 08/13/2021

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: 10/30/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026273477
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE (V-18); GUIDEWIRE (V-18); INFLATION DEVICE (PS25); INFLATION DEVICE (PS25); INTRODUCER SHEATH (DESTINATION 6FR); INTRODUCER SHEATH (DESTINATION 6FR); GUIDEWIRE (V-18); INFLATION DEVICE (PS25); INTRODUCER SHEATH (DESTINATION 6FR)