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	05/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed shunt was located in the moderately tortuous and severely calcified vessel in the left hand.A 4.0 x 40, 75cm mustang balloon was advanced for dilation.However, during the first inflation at 21 atmospheres for 5 seconds, the balloon ruptured.The device was removed and the procedure was completed with a different device.No complications were reported, and the patient was in good condition post-procedure.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.Device evaluated by mfr: the complaint device was received for product analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A balloon longitudinal tear was identified beginning approximately 3mm distal of the distal markerband and extending approximately 13mm proximally across the balloon material.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual and tactile examination found no damage to the tip of the device.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged in the correct position on the device.This concludes the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed shunt was located in the moderately tortuous and severely calcified vessel in the left hand.A 4.0 x 40, 75cm mustang balloon was advanced for dilation.However, during the first inflation at 21 atmospheres for 5 seconds, the balloon ruptured.The device was removed and the procedure was completed with a different device.No complications were reported, and the patient was in good condition post-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: 19366686
• Report Number: 2124215-2024-30736
• Device Sequence Number: 6342635
• Product Code: FGE
• UDI-Device Identifier: 08714729793403
• UDI-Public: 08714729793403
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

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 Expiration Date: 08/03/2025
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0029872660
• 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: 05/14/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2022
• 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
• Patient Sex: Female