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	09/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in central vein.A 12.0 x 60, 75cm mustang balloon catheter was advanced for dilation.However, during inflation at 10 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and patient status was normal.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in central vein.A 12.0 x 60, 75cm mustang balloon catheter was advanced for dilation.However, during inflation at 10 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and patient status was normal.It was further reported that the lesion contained 77% stenosis, severe tortuousity and severe calcification.
Additional Manufacturer Narrative
B5 describe event or problem updated.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.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 12mm proximal from the proximal markerband.An examination of the balloon material and markerbands 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 other 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: 10695569
• Report Number: 2134265-2020-14344
• Device Sequence Number: 11689602
• Product Code: FGE
• UDI-Device Identifier: 08714729794738
• UDI-Public: 08714729794738
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 12/03/2020

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: 08/05/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0025817809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR