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	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 9.0 x 40, 75cm mustang balloon catheter was advanced for dilation.During the procedure, on the first inflation at 6 atmospheres for 20 seconds, the balloon ruptured.The device was removed without any problem and no damage observed.The position of the rupture was found on the middle of the balloon in the shape of a pinhole.Another of the same model was used to complete the procedure.No complications reported, and patient status was good.
Additional Manufacturer Narrative
B5.Describe event or problem: was updated per the additional information provided.
Event or Problem Description
It was reported that balloon rupture occurred.A 9.0 x 40, 75cm mustang balloon catheter was advanced for dilation.During the procedure, on the first inflation at 6 atmospheres for 20 seconds, the balloon ruptured.The device was removed without any problem and no damage observed.The position of the rupture was found on the middle of the balloon in the shape of a pinhole.Another of the same model was used to complete the procedure.No complications reported, and patient status was good.It was further reported that the target lesion was 90% stenosed and was moderately tortuous and moderately calcified located in the iliac artery.

• 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: 19782193
• Report Number: 2124215-2024-44799
• Device Sequence Number: 8278446
• Product Code: FGE
• UDI-Device Identifier: 08714729793489
• UDI-Public: 08714729793489
• 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): 08/13/2024

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: 0033618604
• 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: 07/01/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 07/19/2024
• Supplement Report FDA Received Date: 08/13/2024
• Date Device Manufactured: 03/13/2024
• 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