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	08/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was an area of in-stent restenosis, located in the moderately tortuous and severely calcified common iliac artery.A 9.0 x 20, 75cm mustang balloon catheter was advanced for dilatation.However, during the first inflation at 8 atmospheres for 20 seconds, the balloon ruptured vertically in the middle part.The device was removed, and the procedure was completed with a different device.There were no patient complications reported and the patient was in good condition.

• 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: 17660353
• Report Number: 2124215-2023-46828
• Device Sequence Number: 6161014
• Product Code: FGE
• UDI-Device Identifier: 08714729793755
• UDI-Public: 08714729793755
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2023

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: 10/20/2025
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0030391257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2022
• 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: GUIDEWIRE: CRUISE.; INTRODUCER SHEATH: PARENT PLUS 6F.
• Patient Sex: Unknown