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

Model Number	24674
Medical Device Problem Codes	Leak/Splash (1354); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital.
Event or Problem 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 or Problem 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.
Additional 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
• 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: 18908984
• Report Number: 2124215-2024-15679
• Device Sequence Number: 6410531
• Product Code: FGE
• UDI-Device Identifier: 08714729794233
• UDI-Public: 08714729794233
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

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: 10/20/2025
• 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2022
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 64 KG