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

Model Number	24672
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced blood loss or hemorrhage.A 5.0 x 120, 135cm mustang was selected for vascular case in the right brachial artery.During the procedure, the balloon catheter was introduced through a non-bsc introducer sheath.While insertion was successful, removal of the balloon after it was used was difficult.It required significant force, and which resulted in stretching of the sheath and then the balloon snapped inside the sheaths hub.The sheath had to be removed, and manual pressure was applied to the brachial artery for remainder of case to complete the procedure femorally.Consequently, the patient experienced blood loss or hemorrhage due to this event.The procedure was completed using an alternate method.No further complications were reported, and the patient is expected to fully recover.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20045018
• Report Number: 2124215-2024-48072
• Device Sequence Number: 20862388
• Product Code: FGE
• UDI-Device Identifier: 08714729793410
• UDI-Public: 08714729793410
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/03/2026
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0032349137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 08/23/2024
• Date Device Manufactured: 09/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTRODUCER SHEATH - COOK FLEXOR SHEATH 90CM 5F
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown