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

Model Number 24674

Device Problems Leak/Splash (1354); Material Integrity Problem (2978)

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

Event Date 01/14/2024

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter facility name: (b)(6) hospital.

Event Description

It was reported that balloon pinhole occurred.The target lesion was located in the lower limb.An 8.0 x 100, 135cm mustang balloon catheter was advanced for dilation.During preparation, the pressure of the balloon tip was not enough, and it was leaking water.A visible pinhole was noted on the balloon material.The procedure was completed with another of the same device.No patient complications were reported.

Event Description

It was reported that balloon pinhole occurred.The target lesion was located in the lower limb.An 8.0 x 100, 135cm mustang balloon catheter was advanced for dilation.During preparation, the pressure of the balloon tip was not enough, and it was leaking water.A visible pinhole was noted on the balloon material.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Returned product consisted of a mustang.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured 12mm in length and extended from a position 6mm proximal of the distal markerband to 5mm distal of the distal markerband.A visual examination observed damage to the tip of the device.E1: initial reporter facility name: (b)(6) school of medicine.

• 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: 18908984
• MDR Text Key: 337737802
• Report Number: 2124215-2024-15679
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729794233
• UDI-Public: 08714729794233
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K141521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0030391203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2022
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 64 KG