MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG; CATHETER, BILIARY, DIAGNOSTIC

Model Number	24674
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: a mustang 6 x 6,24atm was returned for analysis.A visual examination of the returned device confirmed that the balloon was tightly wrapped and had not been subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured 2mm in length and extended from a position 20mm proximal of the distal markerband to 22mm proximal of the distal markerband.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.
Event or Problem Description
Reportable based on device analysis completed on 29-apr-2021.It was reported that balloon inflation failure occurred.The stenosed target lesion was located in the femoral artery.After a guidewire was crossed the lesion, a 6.0 x 60, 40cm mustang balloon catheter was advanced for dilatation but the balloon could not inflate.The device was removed from the patient's body and the procedure was completed with a different device.There were no patient complications reported and the patient's status was stable.However, returned device analysis revealed balloon longitudinal tear.

• 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: 11852577
• Report Number: 2134265-2021-06299
• Device Sequence Number: 3724265
• Product Code: FGE
• UDI-Device Identifier: 08714729794783
• UDI-Public: 08714729794783
• 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
• Report Date (Section B): 05/19/2021

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: 05/21/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0023832936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 73