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	03/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon pinhole occurred.Vascular access was obtained via femoral vein.The stenosed target lesion was located in the left iliac vein.A 12.0 x 60, 135cm mustang balloon catheter was advanced for dilation, however, the balloon did not inflate when it reaches 4 to 6 atmospheres (atm).The pressure was and the device removed.When the physician tried to inflate the balloon at 6 atm outside the patient, liquid leaked at the connection part between the balloon and the marker and a pinhole was noted on the balloon material.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.
Event or Problem Description
It was reported that balloon pinhole occurred.Vascular access was obtained via femoral vein.The stenosed target lesion was located in the left iliac vein.A 12.0 x 60, 135cm mustang balloon catheter was advanced for dilation, however, the balloon did not inflate when it reaches 4 to 6 atmospheres (atm).The pressure was and the device removed.When the physican tried to inflate the balloon at 6 atm outside the patient, liquid leaked at the connection part between the balloon and the marker and a pinhole was noted on the balloon material.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: a mustang 12.0 x 60, 135cm was returned for analysis.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 18mm proximal from the distal markerband.No other issues were noted.A visual and microscopic examination of the balloon material identified no other issues.The rated burst pressure for this device was 14 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.A visual and tactile examination identified no damage to the tip.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: 10080018
• Report Number: 2134265-2020-05796
• Device Sequence Number: 16871694
• Product Code: FGE
• UDI-Device Identifier: 08714729795018
• UDI-Public: 08714729795018
• 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): 06/23/2020

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: 06/10/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0023931885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Initial Date Received by Manufacturer: 04/27/2020
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 06/23/2020
• 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
• Patient Weight: 65