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

Model Number	24672
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a vessel below the knee.A 3.0 x 150, 135cm mustang balloon catheter was advanced for dilation.However, during inflation at 20 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with a different device.No patient complications were reported and the patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a vessel below the knee.A 3.0 x 150, 135cm mustang balloon catheter was advanced for dilation.However, during inflation at 20 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with a different device.No patient complications were reported and the patient status was stable.It was further reported that the 80% stenosed target lesion was located in a non-calcified and straight vessel.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr.: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A microscopic examination identified a balloon longitudinal tear beginning approximately 58mm distal of the proximal markerband and extending approximately 18mm distally across the balloon material.An examination of the balloon material and distal markerband identified no issues.A visual and microscopic examination of the markerbands identified no issues.A visual and tactile examination identified no kinks or damage to the shaft.A visual and tactile examination identified no damage to the tip.No issues were identified during the product analysis.

• 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: 9622486
• Report Number: 2134265-2020-00249
• Device Sequence Number: 19323929
• Product Code: LIT
• UDI-Device Identifier: 08714729794516
• UDI-Public: 08714729794516
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K103751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

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: 07/28/2022
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0024178485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Initial Date Received by Manufacturer: 01/04/2020
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1