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

Model Number 24672

Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)

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

Event Date 11/29/2021

Event Type  malfunction  

Event Description

It was reported the balloon burst circumferentially and detached. A 7. 0 x 150, 75cm mustang balloon was selected for use in a percutaneous transluminal angioplasty (pta) of the 90% stenosed, mildly tortuous and severely calcified superficial femoral artery (sfa). During the first inflation, the balloon burst circumferentially approximately 5cm from the tip. During removal, the distal portion broke off and was able to be removed from the patient still on the guidewire with out any complications. The procedure was completed with another device and no patient complications were reported.

• 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; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12953475
• Report Number: 2134265-2021-15398
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729794578
• UDI-Public: 08714729794578
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K103751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0026069326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sex: No Answer Provided
• Patient Weight: KG