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

Model Number	24674
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon became stuck with the guidewire.An 8.0 x 60, 75cm mustang was advanced for dilatation.However, during the procedure it was noted that the guidewires became stuck in balloon wire shaft after inserting into patient.The balloon and guidewire have to be removed as one unit through sheath.The balloon was deflated prior to removal attempt and was removed intact.The guidewire was not able to be removed from the device once outside the patient.The procedure was completed using an alternate device.No patient complications were reported.
Event or Problem Description
It was reported that balloon became stuck with the guidewire.The target lesion was located in the arteriovenous fistula in arm.An 8.0 x 60, 75cm mustang was advanced for dilatation.However, during the procedure it was noted that the guidewires became stuck in balloon wire shaft after inserting into patient.The balloon and guidewire have to be removed as one unit through sheath.The balloon was deflated prior to removal attempt and was removed intact.The guidewire was not able to be removed from the device once outside the patient.The procedure was completed using an alternate device.No patient complications were reported.
Additional Manufacturer Narrative
Device was returned for evaluation.A visual examination identified that the balloon wings were tightly wrapped and had not been subjected to positive pressure.A visual examination of the marker bands identified no issues.As per mustang product specification, a 0.035 guidewire is required for this device.The device was received with the customers guidewire inserted in the device.A shaft kink was noted 250mm distal, from the distal end of the strain relief.The investigator was unable to remove the customers guidewire due to the shaft kink.A visual and tactile examination identified no damage to the tip of the device.No other issues were identified with the device and no patient complications were reported.

• 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: 19577086
• Report Number: 2124215-2024-35168
• Device Sequence Number: 19873705
• Product Code: FGE
• UDI-Device Identifier: 08714729793885
• UDI-Public: 08714729793885
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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: 03/19/2026
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0031262695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2023
• 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 Sex: Unknown