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

Model Number	24672
Medical Device Problem Codes	Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via the right femoral artery.The 70% stenosed, 7mm x 3mm target lesion was located in the non-tortuous and moderately calcified superficial femoral artery.A 5.0 x 150, 135cm mustang balloon catheter was advanced for pre-dilatation.However, during introduction, the device failed to pass through a 6fr sheath.The sheath and the 0.035 260cm zipwire guidewire were replaced but the device was difficult to track over the guidewire.During the first inflation at 5 atmospheres for 30 seconds, the balloon ruptured.The device was removed, and the procedure was completed with another of same device.There were no complications reported and the patient status was stable.

• 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: 18232456
• Report Number: 2124215-2023-66623
• Device Sequence Number: 17930277
• Product Code: LIT
• UDI-Device Identifier: 08714729793434
• UDI-Public: 08714729793434
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/29/2023

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: 10/03/2025
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0030271238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2022
• 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: GUIDE CATHETER: 5FR BERN; GUIDEWIRE: 0.035 260CM ZIPWIRE
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 80 KG