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	09/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon tear occurred.The target lesion was located in the common bile duct.A 12.0 x 20, 135cm mustang balloon catheter was advanced for use.However, when pressure pump was injected with contrast agent, the balloon did not fully inflate.When the device was removed and flushed outside the patient's body, a balloon tear was noted.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.
Event or Problem Description
It was reported that balloon tear occurred.The target lesion was located in the common bile duct.A 12.0 x 20, 135cm mustang balloon catheter was advanced for use.However, when pressure pump was injected with contrast agent, the balloon did not fully inflate.When the device was removed and flushed outside the patient's body, a balloon tear was noted.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: mustang 12 x 2 135cm was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear beginning approximately 2mm proximal of the proximal balloon sleeve and extending approximately 3mm distally.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.As per mustang specification the rated burst pressure for this device is 14 atmospheres.A visual and microscopic examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.No other issues were identified during 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: 10682833
• Report Number: 2134265-2020-13847
• Device Sequence Number: 3208205
• Product Code: FGE
• UDI-Device Identifier: 08714729794356
• UDI-Public: 08714729794356
• 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): 11/13/2020

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: 10/05/2020
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0021224724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 75