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

Model Number	24674
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the radial cutaneous vein.A 4.0 x 20, 40cm mustang balloon catheter was advanced for dilation.However, during the procedure, a pinhole-like rupture in the balloon or shaft occurred.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the radial cutaneous vein.A 4.0 x 20, 40cm mustang balloon catheter was advanced for dilation.However, during the procedure, a pinhole-like rupture in the balloon or shaft occurred.There were no patient complications nor injuries reported.It was further reported that the target lesion was 75% stenosed.The balloon ruptured during the second inflation at 10 atmospheres for 10 seconds, and there was a pinhole noted on the shaft.The procedure was completed with a different device.
Additional Manufacturer Narrative
Device evaluated by mfr.: a mustang balloon catheter was returned for analysis.A visual examination identified that the balloon had been inflated.A leak test found a pinhole in the shaft of the device.Tip damage was also noted.No issues were identified with the balloon material or markerbands.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the radial cutaneous vein.A 4.0 x 20, 40cm mustang balloon catheter was advanced for dilation.However, during the procedure, a pinhole-like rupture in the balloon or shaft occurred.There were no patient complications nor injuries reported.It was further reported that the target lesion was 75% stenosed.The balloon ruptured during the second inflation at 10 atmospheres for 10 seconds, and there was a pinhole noted on the shaft.The procedure was completed with a different device.

• 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: 12560088
• Report Number: 2134265-2021-12333
• Device Sequence Number: 1428931
• Product Code: FGE
• UDI-Device Identifier: 08714729794172
• UDI-Public: 08714729794172
• 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,Followup
• Report Date (Section B): 11/02/2021

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: 10/16/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026197323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 10/04/2021; 10/21/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 10/19/2021; 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1