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

Model Number	24674
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon leak occurred.The target lesion was located in the iliac vein.A 12.0 x 80, 135cm mustang balloon catheter was advanced for dilation.However, when visualizing through angiography, the balloon did not expand.When the balloon was removed, it was observed that it was broken.The procedure was completed and there were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr: a mustang 12.0 x 80, 135cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A visual examination identified a balloon longitudinal tear beginning approximately 5mm distal of the proximal markerband and extending approximately 3mm distally across the balloon material.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.
Event or Problem Description
It was reported that balloon leak occurred.The target lesion was located in the iliac vein.A 12.0 x 80, 135cm mustang balloon catheter was advanced for dilation.However, when visualizing through angiography, the balloon did not expand.When the balloon was removed, it was observed that it was broken.The procedure was completed and 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12272169
• Report Number: 2134265-2021-09695
• Device Sequence Number: 19715880
• Product Code: FGE
• UDI-Device Identifier: 08714729795285
• UDI-Public: 08714729795285
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2021

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: 03/02/2024
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026909485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male