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

Model Number	24674
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture and shaft break occurred.The target lesion was located in the moderately tortuous and moderately calcified arteriovenous fistula.A 12.0 x 80, 75cm mustang balloon catheter was advanced for dilation.However, after the balloon was inflated more than three times at above 20 atmospheres, the balloon burst.It was also noted that the middle of the catheter was separated outside the patient.The device was simply pulled out, and the procedure was completed with another of the same device.No patient complications were reported, and the patient condition was stable.
Event or Problem Description
It was reported that balloon rupture and shaft break occurred.The target lesion was located in the moderately tortuous and moderately calcified arteriovenous fistula.A 12.0 x 80, 75cm mustang balloon catheter was advanced for dilation.However, after the balloon was inflated more than three times at above 20 atmospheres, the balloon burst.It was also noted that the middle of the catheter was separated outside the patient.The device was simply pulled out, and the procedure was completed with another of the same device.No patient complications were reported, and the patient condition was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: mustang 12.0 x 80, 75cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A complete balloon circumferential tear was identified located approximately 50mm distal of the proximal balloon bond.This type of damage most probably occurred when the device was being withdrawn through the sheath.The distal section of balloon material including a section of shaft, the distal markerband and tip of the device was not returned for analysis.The rated burst pressure for this device as per mustang specification is 14 atmospheres.A visual and tactile examination found the shaft of the device to have completely separated at a location proximal of the distal tip bond.The distal section of shaft including the distal section of balloon material, the distal markerband and tip of the device was not returned for analysis.The shaft is also severely stretched distal of the proximal markerband.The distal section of the device including a section of balloon material, a section of shaft the distal markerband and tip of the device was not returned for analysis.A visual examination observed that the distal section of the device including the distal markerband, a section of balloon material, a section of shaft and tip of the device was not returned for analysis.The proximal markerband was undamaged in the correct position on 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16655793
• Report Number: 2124215-2023-15205
• Device Sequence Number: 12243314
• Product Code: FGE
• UDI-Device Identifier: 08714729794745
• UDI-Public: 08714729794745
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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: 08/11/2025
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0029940916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2022
• 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: 82 YR
• Patient Sex: Female