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	06/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the iliac artery.A 7.0 x 60, 75cm mustang balloon catheter was advanced for dilation.However, during initial inflation, the balloon deflated before it reached to its rated burst pressure.The procedure was completed with another of the same devices.No patient complications were reported, and the patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the iliac artery.A 7.0 x 60, 75cm mustang balloon catheter was advanced for dilation.However, during initial inflation, the balloon deflated before it reached to its rated burst pressure.The procedure was completed with another of the same devices.No patient complications were reported, and the patient status was stable.It was further reported that the target lesion was 60% stenosed, non-tortuous, and mildly calcified.
Additional Manufacturer Narrative
Device evaluated by mfr: mustang 7.0 x 60, 75cm was received for analysis.The following attributes were examined.The device was received in two sections due to device separation.A visual examination identified that the balloon was not folded which indicates that it was subjected to positive pressure.A complete balloon circumferential tear was identified located at the proximal balloon bond.From the complete circumferential tear, the distal section of balloon material was also torn longitudinally along its entire length.No other issues were noted with the balloon material.As per mustang specification, the rated burst pressure for this device is 20 atmospheres.A visual examination observed no damage to the tip of the device.A visual and tactile examination found the shaft of the device to have separated at approximately 30mm proximal of the distal markerband.This type of damage is consistent with excessive tensile force being applied to the device.The shaft was also noted to be severely kinked at more than one location.Both markerbands were undamaged and present on the shaft of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the iliac artery.A 7.0 x 60, 75cm mustang balloon catheter was advanced for dilation.However, during initial inflation, the balloon deflated before it reached to its rated burst pressure.The procedure was completed with another of the same devices.No patient complications were reported, and the patient status was stable.It was further reported that the target lesion was 60% stenosed, non-tortuous and non-calcified.

• 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: 17264267
• Report Number: 2124215-2023-34571
• Device Sequence Number: 20311008
• Product Code: FGE
• UDI-Device Identifier: 08714729793861
• UDI-Public: 08714729793861
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/02/2023

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: 10/19/2025
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0030381903
• 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: 06/30/2023
• Supplement Date Received by Manufacturer: 07/13/2023; 07/31/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 07/17/2023; 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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