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	08/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).Age at time of event - 18 years or older.
Event or Problem Description
It was reported that balloon burst occurred.The stenosed target lesion was located in an arteriovenous shunt in the upper limb.A 7.0 x 80, 75cm mustang balloon catheter was advanced for dilation.However, during inflation, the balloon burst when the atmospheric pressure was 20 kpa.The device was removed and the procedure was completed with another of same device.There were no patient complications nor injuries 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: 12430978
• Report Number: 2134265-2021-11296
• Device Sequence Number: 17191212
• Product Code: FGE
• UDI-Device Identifier: 08714729794264
• UDI-Public: 08714729794264
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/06/2021

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: 04/26/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0025470741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1