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	07/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 60% stenosed target lesion was located in the mildly tortuous arteriovenous fistula.A 7.0 x 60, 135cm mustang balloon catheter was advanced to dilate the lesion.However, during the first inflation the balloon ruptured.The device was completely removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The 60% stenosed target lesion was located in the mildly tortuous ateriovenous fistula.A 7.0 x 60, 135cm mustang balloon catheter was advanced to dilate the lesion.However, during the first inflation the balloon ruptured.The device was completely removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.Device evaluated by mfr: the device was returned for analysis.A visual and microscopic examination identified that the device had been inflated and had not been refolded.Blood was identified inside the balloon which is evidence of a device leak.The returned device was attached to an encore inflation unit and positive pressure was applied.The investigator was unable to inflate the balloon due to a pinhole on the shaft of the device.No issues were identified with the balloon material that could have contributed to the complaint incident.A visual and microscopic examination identified no issues with the tip or markerbands that could have contributed to the complaint incident.A visual and tactile examination of the shaft identified no kinks on the shaft of the device.During inflation of the balloon liquid was noted to be exiting from a pinhole on the shaft of the device.No other issues were noted with the shaft which could potentially have 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: 7781572
• Report Number: 2134265-2018-60068
• Device Sequence Number: 16465562
• Product Code: FGE
• UDI-Device Identifier: 08714729794325
• UDI-Public: 08714729794325
• 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): 09/19/2018

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: 08/01/2020
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0020963857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1