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 Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 12.0 x 40, 135cm mustang balloon catheter was advanced for dilatation.However, during inflation, it was noticed that the balloon did not reach at 14 atmospheres.Initially, it was believed that the lesion was elastic and would require a high pressure balloon.When the balloon was removed and inflated outside the patient, it was verified that the balloon was punctured.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluation by mfr.: a mustang 12.0 x 40, 135cm was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied and liquid was observed to be leaking from a balloon pinhole located approximately 2mm distal of the distal marker band.An examination of the balloon material and distal marker band identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination of the marker bands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination found no issues with the device shaft.A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.A 12.0 x 40, 135cm mustang balloon catheter was advanced for dilatation.However, during inflation, it was noticed that the balloon did not reach at 14 atmospheres.Initially, it was believed that the lesion was elastic and would require a high pressure balloon.When the balloon was removed and inflated outside the patient, it was verified that the balloon was punctured.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: 9866362
• Report Number: 2134265-2020-03304
• Device Sequence Number: 468931
• Product Code: FGE
• UDI-Device Identifier: 08714729793953
• UDI-Public: 08714729793953
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2020

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: 09/16/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0024442335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR