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

Model Number	24674
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip detachment occurred.A 5.0 x 20, 135cm mustang balloon catheter was selected for use.However, during unpacking of the balloon, it was noticed that the distal tip of the balloon delivery system was fractured.The procedure was completed with a different device.There were no patient complications reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: a mustang 5mm x 2cm,135cm was returned for analysis.A visual and tactile examination identified that the balloon was tightly folded and had not been subjected to positive pressure.No issues were noted which may have potentially contributed to the complaint incident.A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination identified a shaft kink 4mm distal from distal end of strain relief.A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that tip detachment occurred.A 5.0 x 20, 135cm mustang balloon catheter was selected for use.However, during unpacking of the balloon, it was noticed that the distal tip of the balloon delivery system was fractured.The procedure was completed with a different device.There were no patient complications reported and the patient status was stable.

• 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: 11785860
• Report Number: 2134265-2021-05716
• Device Sequence Number: 3659821
• Product Code: FGE
• UDI-Device Identifier: 08714729793618
• UDI-Public: 08714729793618
• 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): 06/16/2021

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: 03/20/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0025384162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 68