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

Model Number	24674
Medical Device Problem Codes	Leak/Splash (1354); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon pinhole occurred.The stenosed target lesion was located in the iliac artery.After a guidewire was crossed the lesion, a 10.0 x 80, 135cm mustang balloon catheter was advanced for dilation.However, when the balloon was inflated at rated pressure, the contrast agent was found to leak.The device was removed and a pinhole was noticed on the balloon.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.
Event or Problem Description
It was reported that balloon pinhole occurred.The stenosed target lesion was located in the iliac artery.After a guidewire was crossed the lesion, a 10.0 x 80, 135cm mustang balloon catheter was advanced for dilation.However, when the balloon was inflated at rated pressure, the contrast agent was found to leak.The device was removed and a pinhole was noticed on the balloon.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: mustang device - 10x8x135cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device 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 markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.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 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.

• 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: 10930840
• Report Number: 2134265-2020-16551
• Device Sequence Number: 2649564
• Product Code: FGE
• UDI-Device Identifier: 08714729795254
• UDI-Public: 08714729795254
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2020

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: 04/30/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0023723336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 12/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 57