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	06/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in radial artery.A 5.0 x 60, 75cm mustang balloon catheter was advanced for dilation.However, during second inflation at 10 atmospheres for 30 seconds, the balloon ruptured.The procedure was completed with a different device.There were no patient complications reported and the patient condition was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the radial artery.A 5.0 x 60, 75cm mustang balloon catheter was advanced for dilation.However, during second inflation, it was noted that the balloon burst at 10 atmospheres for 30 seconds duration time while blowing it inside the patient's body.The procedure was completed with a different device.There were no patient complications reported.It was further reported that the target lesion was severely tortuous and severely calcified.
Additional Manufacturer Narrative
B5.Describe event or problem- updated.Device evaluated by mfr.: a mustang 5mm x 6cm, 75cm was received 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 measured 10 mm in length and extended from a position 11 mm proximal of the distal markerband to 1 mm proximal of the distal markerband.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 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 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: 12088747
• Report Number: 2134265-2021-08254
• Device Sequence Number: 3870682
• Product Code: FGE
• UDI-Device Identifier: 08714729793977
• UDI-Public: 08714729793977
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 08/23/2021

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: 02/01/2024
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026729808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 08/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR