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	08/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the superior vena cava.A 12.0 x 60, 135 cm mustang balloon catheter was advanced for dilation.However, during procedure, it was noted that the balloon burst.The procedure was completed with another of the same device.No patient complications were reported and patient's status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the superior vena cava.A 12.0 x 60, 135cm mustang balloon catheter was advanced for dilation.However, during procedure, it was noted that the balloon burst.The procedure was completed with another of the same device.No patient complications were reported and patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.A visual examination of the returned device confirmed that the balloon had been subjected to positive pressure.A microscopic examination identified a balloon longitudinal tear beginning approximately 17mm distal of the proximal markerband and extending approximately 4mm distally across the balloon material.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this damage identified.A visual and microscopic examination was performed on the returned device.The tip of the device was damaged.This type of damage is consistent with excess force being applied as a result of meeting resistance during the attempt to cross a lesion.No issues were noted with the tip that could have contributed to the complaint incident.A visual and tactile examination found no kinks or damage along the shaft of the device.No other issues were noted with the device.

• 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: 9016134
• Report Number: 2134265-2019-11177
• Device Sequence Number: 2502697
• 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): 10/16/2019

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: 08/28/2021
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0022583961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 68