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

Model Number	24674
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 28mar2024.It was reported that the catheter was unable to cross the lesion.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 4.0 x 100, 75cm mustang was selected for endovascular therapy (evt).During the procedure, it was noted that the catheter was unable to cross the lesion.The procedure was completed with a different device.No complications were reported and the patient was stable post-procedure.However, device analysis revealed a partial balloon circumferential tear located approximately 17mm proximal of the distal markerband.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A partial balloon circumferential tear was identified located approximately 17mm proximal of the distal markerband.This type of damage most probably occurred when the user attempted to withdraw the device through the sheath.The rated burst pressure for this device as per specification is 24 atmospheres.A visual and tactile examination found the shaft of the device to be kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.A visual examination found no issues with the tip of the device.A visual examination found no issues with the markerbands of the device.This concludes the product analysis.

• 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: 19094792
• Report Number: 2124215-2024-21770
• Device Sequence Number: 20690088
• Product Code: FGE
• UDI-Device Identifier: 08714729794240
• UDI-Public: 08714729794240
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2024

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: 03/07/2024
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026927259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2021
• 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