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

Model Number	24674
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a hole on the balloon was noted.The target lesion was located in the iliac artery.A 12.0 x 80, 135cm mustang balloon catheter was advanced for dilatation.However, during the procedure, the physician found that the balloon was leaking and had a hole on it.The balloon was simply removed from the patient's body and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
H6 device codes corrected from leak/splash 1354 to material rupture 1546.The complaint device was returned for analysis.Blood was identified in the balloon which was indicative of a 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 13mm proximal from the proximal markerband.No other issues were noted.A visual and microscopic examination of the balloon material identified no issues that could have contributed to the complaint incident.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.
Event or Problem Description
It was reported that a hole on the balloon was noted.The target lesion was located in the iliac artery.A 12.0 x 80, 135cm mustang balloon catheter was advanced for dilatation.However, during the procedure, the physician found that the balloon was leaking and had a hole on it.The balloon was simply removed from the patient's body and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• 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: 9511738
• Report Number: 2134265-2019-16041
• Device Sequence Number: 11148478
• Product Code: FGE
• UDI-Device Identifier: 08714729795285
• UDI-Public: 08714729795285
• 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): 03/10/2020

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: 06/25/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0024016936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 63