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

Model Number	24672
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation by mfr.: a mustang 5.0 x 120, 135cm was returned for analysis.Blood was in the balloon which was indicative of leak.The returned device was loaded onto a mandrel and attached to an encore inflation unit.Positive pressure was applied, and a pinhole leak was identified in the centre of the balloon.No other issues were noted.A visual and microscopic examination of the balloon material identified no other 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.
Event or Problem Description
Reportable based on device analysis completed on 05aug2020.It was reported that balloon leak occurred.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified superficial femoral artery.A 5.0 x 120, 135cm mustang balloon catheter was advanced for post-dilatation.However, after dilatation, angiography image showed leaking of contrast agent.The procedure was completed with another of the same device.No patient complications were reported and the patient condition was fine.However, returned device analysis revealed balloon pinhole.

• 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: 10457045
• Report Number: 2134265-2020-10981
• Device Sequence Number: 3524841
• Product Code: FGE
• UDI-Device Identifier: 08714729793410
• UDI-Public: 08714729793410
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K103751
• 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
• Report Date (Section B): 08/26/2020

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: 02/25/2023
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0025267044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR