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	09/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified iliac artery.A 9.0 x 20, 75cm mustang balloon was advanced for dilation.However, during the first inflation, the balloon ruptured.The procedure was completed with a non-boston scientific (bsc) device.No patient injury was reported.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified iliac artery.A 9.0 x 20, 75cm mustang balloon was advanced for dilation.However, during the first inflation, the balloon ruptured.The procedure was completed with a non-boston scientific (bsc) device.No patient injury was reported.It was further reported that the balloon ruptured at 12 atmospheres for 60 seconds.The device was removed without any problem using the normal method, and the patient was in good condition after the procedure.

• 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: 20461762
• Report Number: 2124215-2024-64322
• Device Sequence Number: 18318264
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

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 Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0034533455
• 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: 09/25/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 10/28/2024
• Date Device Manufactured: 07/30/2024
• 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
• Patient Sex: Unknown