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	11/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via the femoral artery.The target lesion was located in the mildly calcified subclavian vein.A 12.0 x 60, 135cm mustang balloon catheter was advanced for dilation.However, it was noted that the balloon ruptured at nominal atmospheric pressure.The procedure was completed with a 12x80 mustang balloon catheter.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via the femoral artery.The target lesion was located in the mildly calcified subclavian vein.A 12.0 x 60, 135cm mustang balloon catheter was advanced for dilation.However, it was noted that the balloon ruptured at nominal atmospheric pressure.The procedure was completed with a 12x80 mustang balloon catheter.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.:device was returned for analysis.Blood was identified in the balloon which is indicative of a device leak.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.No tears or holes were visible in the balloon.The device was attached to an encore inflation device and positive pressure was applied, however the balloon did not inflate.The device was soaked in the waterbath at 37 degrees celsius to soften hardened medium or blood that may have been present in the device.The device was removed from the bath and was attached to an encore inflation device and positive pressure was applied.A pinhole leak was identified mid balloon.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.The rated burst pressure for this device is 24 atmospheres as per the print on the hub.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: 9462294
• Report Number: 2134265-2019-15717
• Device Sequence Number: 3104030
• Product Code: FGE
• UDI-Device Identifier: 08714729795018
• UDI-Public: 08714729795018
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 02/28/2020

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: 10/31/2021
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0022873391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 58