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	12/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed, target lesion was located in a shunt in the moderately tortuous and severely calcified upper arm.A 4.0 x 40, 40cm mustang balloon catheter was advanced for dilatation.However, during the second inflation at 10 atmospheres for a few seconds, the balloon ruptured.The device was completely removed and the procedure was completed with another of the same device.There were no patient complications reported and the patient was in good condition.
Additional Manufacturer Narrative
Device evaluated by mfr.: mustang 4.0 x 40, 40cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that it was subjected to positive pressure.A partial balloon circumferential tear was identified located approximately 15mm distal of the distal markerband.From the partial circumferential tear, the balloon was also torn longitudinally for approximately 27mm distally.No other issues were noted with the balloon material.As per mustang specification, the rated burst pressure for this device is 24 atmospheres.A visual examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.This concludes the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed, target lesion was located in a shunt in the moderately tortuous and severely calcified upper arm.A 4.0 x 40, 40cm mustang balloon catheter was advanced for dilatation.However, during the second inflation at 10 atmospheres for a few seconds, the balloon ruptured.The device was completely removed and the procedure was completed with another of the same 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; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16025406
• Report Number: 2124215-2022-54144
• Device Sequence Number: 7184134
• Product Code: FGE
• UDI-Device Identifier: 08714729794103
• UDI-Public: 08714729794103
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2023

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: 07/19/2025
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0029796211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2022
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2022
• 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
• Patient Sex: Unknown