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	06/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in a shunt in the mildly tortuous and moderately calcified radial vein artery.A 3.0 x 40, 75cm mustang balloon catheter was advanced for dilation.However, during the inflation, the balloon ruptured.The device removed, and the procedure was completed with a different device.There were no patient injuries reported and the patient was in good condition post procedure.
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in a shunt in the mildly tortuous and moderately calcified radial vein artery.A 3.0 x 40, 75cm mustang balloon catheter was advanced for dilation.However, during the inflation, the balloon ruptured.The device removed, and the procedure was completed with a different device.There were no patient injuries reported and the patient was in good condition post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: a mustang device was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A visual examination of the balloon material identified no issues which could potentially have contributed to this complaint.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied but the balloon could not be fully inflated due to a shaft leak.The markerbands and tip of the device were visually examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied, and liquid was observed to be exiting from a shaft pinhole located approximately 8mm proximal of the proximal markerband.The shaft was noted to be damaged.

• 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: 17181797
• Report Number: 2124215-2023-32377
• Device Sequence Number: 15077006
• Product Code: FGE
• UDI-Device Identifier: 08714729793946
• UDI-Public: 08714729793946
• 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): 07/17/2023

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: 08/08/2024
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0027800420
• 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: 06/13/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2021
• 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