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

Model Number 24674

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/18/2023

Event Type  Injury  

Event Description

It was reported that balloon detachment occurred.A 10.0 x 40, 75cm mustang balloon catheter was advanced for dilation.However, during insertion of the device, the balloon detached.The physician feels like the device was removed without any parts left by pulling and the procedure was aborted, and the vein had to be sutured.

• Brand Name: MUSTANG
• Type of Device: 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: 17738182
• MDR Text Key: 323303664
• Report Number: 2124215-2023-46564
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729793359
• UDI-Public: 08714729793359
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0030542086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/13/2023
• Date Device Manufactured: 11/15/2022
• 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
• Patient Outcome(s): Required Intervention