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

Model Number	24673
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon detachment occurred inside the patient requiring additional intervention.The target lesion was located in the highly calcified superficial femoral artery.A 6.0 x 200, 135cm mustang balloon catheter was selected and advanced.During the procedure, the balloon got detached inside the patient when attempting to withdraw it.The physician tried to use a clover snare to retrieve the balloon from the patient but was unsuccessful.The vessel had to be opened and the balloon was cut down in order to remove it.As the vessel was highly calcified, it was assumed that the device got caught on a stent or a piece of hard plaque that caused the detachment.The procedure was completed with this device, and there were no patient complications reported.
Event or Problem Description
It was reported, that balloon detachment occurred inside the patient.Requiring additional intervention.The target lesion was located in the highly calcified superficial femoral artery.A 6.0 x 200, 135cm mustang balloon catheter was selected and advanced.During the procedure, the balloon got detached inside the patient when attempting to withdraw it.The physician tried to use a clover snare to retrieve the balloon from the patient, but was unsuccessful.The vessel had to be opened and the balloon was cut down in order to remove it.As the vessel was highly calcified, it was assumed, that the device got caught on a stent or a piece of hard plaque that caused the detachment.The procedure was completed with this device.And there were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: device was returned for analysis.And underwent a visual and tactile examination.A complete balloon circumferential tear was identified, located approximately 5mm distal of the proximal balloon sleeve.The proximal section of balloon material was also torn.Longitudinally beginning approximately 6mm distal of the proximal balloon sleeve.And extending approximately, 25mm distally across the balloon material.The shaft was detached 10mm distal from the proximal balloon sleeve.The inner shaft was severely stretched and accordion.The proximal markerband was also detached from the shaft.No damages were noted, on the tip of the device.

• 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: 19312027
• Report Number: 2124215-2024-28562
• Device Sequence Number: 20560663
• Product Code: LIT
• UDI-Device Identifier: 08714729793380
• UDI-Public: 08714729793380
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K103751
• 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): 07/18/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2026
• Device Model Number: 24673
• Device Catalogue Number: 24673
• Device Lot Number: 0031578187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown