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	09/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the aorta abdominalis.A 7.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.However, during the first inflation at less than rated burst pressure for few seconds, the balloon ruptured.The device was removed and the procedure was completed.No patient complications nor injuries reported and the patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the aorta abdominalis.A 7.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.However, during the first inflation at less than rated burst pressure for few seconds, the balloon ruptured.The device was removed and the procedure was completed.No patient complications nor injuries reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: mustang 7.0 x 60, 75cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.Blood was identified within the balloon which is evidence of a device leak.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 8mm proximal of the proximal markerband.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 20 atmospheres.A visual examination observed no issues or damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged and present on the shaft of 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: 12576681
• Report Number: 2134265-2021-12432
• Device Sequence Number: 17016245
• Product Code: FGE
• UDI-Device Identifier: 08714729793861
• UDI-Public: 08714729793861
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/04/2021

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: 11/20/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026399268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Initial Date Received by Manufacturer: 09/26/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 11/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 60