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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 7.0 x 80, 135cm mustang balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured before reaching rated burst pressure.The device was removed and the procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
Event or Problem Description
It was reported that balloon rupture occurred.A 7.0 x 80, 135cm mustang balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured before reaching rated burst pressure.The device was removed and the procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
Additional Manufacturer Narrative
D4: lot number corrected from 0025314650 to 0024403274.D4: expiration date corrected from 03/05/2023 to 09/09/2022.D4: unique identifier (udi) # corrected from (b)(4).H4.Device manufacture date corrected from 03/05/2020 to 09/10/2019.Device evaluated by mfr.: a mustang 7 x 8, 75cm was returned for analysis.As per mustang specification the recommended sheath for this device is minimum 5fr.The sheath used by the customer was not returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A full balloon circumferential tear was identified located approximately 8mm proximal of the proximal balloon markerband.From the circumferential tear the balloon was also torn longitudinally for approximately 55mm distally.There was also bunching visible in the distal region of the balloon.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip of the device.A visual and tactile examination identified inner shaft damage 87mm proximal from the distal tip.Both markerbands were undamaged and present on the shaft of the device.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: 11325668
• Report Number: 2134265-2021-01683
• Device Sequence Number: 19874397
• Product Code: FGE
• UDI-Device Identifier: 08714729794288
• UDI-Public: 08714729794288
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K141521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

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: 09/09/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0024403274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1