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

Model Number	24674
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2020
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 pinhole occurred.Vascular access was obtained via the femoral artery.A 10.0 x 40, 135cm mustang balloon catheter was advanced for use.However, during balloon inflation, contrast solution leaked outside of the catheter from what appeared to be a pinhole.The procedure was completed with a different device.No patient complications reported and the patient's status was stable.
Event or Problem Description
It was reported that balloon pinhole occurred.Vascular access was obtained via the femoral artery.A 10.0 x 40, 135cm mustang balloon catheter was advanced for use.However, during balloon inflation, contrast solution leaked outside of the catheter from what appeared to be a pinhole.The procedure was completed with a different device.No patient complications reported and the patient's status was stable.It was further reported that the 30-40% stenosed target lesion was located in the iliac zone and that there was no significant calcification or tortuosity.
Additional Manufacturer Narrative
A2 age at time of event: 18 years or older.H6 device codes corrected from material puncture/hole 1504 to material rupture 1546.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 10mm proximal of the proximal markerband.An examination of the balloon material and a visual and microscopic examination markerbands identified no issues which could potentially have contributed to this complaint.A visual and tactile examination identified no kinks or damage to the shaft which may have potentially contributed to the complaint incident.A visual and microscopic 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.

• 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: 9733749
• Report Number: 2134265-2020-01645
• Device Sequence Number: 2353050
• Product Code: FGE
• UDI-Device Identifier: 08714729793823
• UDI-Public: 08714729793823
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K141521
• 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): 04/08/2020

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: 06/04/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0023904988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1