MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG; CATHETER, BILIARY, DIAGNOSTIC

Model Number 24674

Device Problems Leak/Splash (1354); Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter city: (b)(6).

Event Description

It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified common iliac artery.A 8.0 x 40, 135cm mustang balloon catheter was advanced for dilation.However, during first inflation at 8 atmospheres for 8 seconds, slow contrast medium leakage was noted and the balloon ruptured.The device was removed and the procedure was completed with a different device.There were no patient complications nor injuries reported and the patient condition was good.

• Brand Name: MUSTANG
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12850415
• MDR Text Key: 281080580
• Report Number: 2134265-2021-14630
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729793663
• UDI-Public: 08714729793663
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0024252913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2021
• Initial Date FDA Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE: CRUISE 300; INTRODUCER SHEATH: DESTINATION