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 Consequences Or Impact To Patient (2199)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a vessel in the arm.A 7.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.However, during the second inflation below the rated burst pressure, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
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 complete balloon circumferential tear was identified located approximately 40mm distal of the proximal markerband.The distal section of the balloon material had been pushed distally towards the tip of the device.This type of damage potentially occurred when the device was being withdrawn through the sheath.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A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 damage to the tip of the device.This type of damage is consistent with the device encountering resistance when crossing the lesion.A visual and tactile examination found the shaft of the device to be severely kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.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 a vessel in the arm.A 7.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.However, during the second inflation below the rated burst pressure, the balloon ruptured.The procedure was completed with another of the same 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: 9672086
• Report Number: 2134265-2020-00994
• Device Sequence Number: 379555
• Product Code: FGE
• UDI-Device Identifier: 08714729793861
• UDI-Public: 08714729793861
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2020

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: 07/21/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0024143410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 70