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

Model Number	24674
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the mildly tortuous and non-calcified upper arm arteriovenous fistula.A 7.0 x 80, 75cm mustang balloon catheter was advanced for dilatation.However, during inflation at 12 atmospheres for 30 seconds, the balloon burst.The device was removed, and the procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient condition was normal.
Additional Manufacturer Narrative
Device evaluated by mfr.: a mustang device was received for analysis.The device was received in two sections due to shaft break located 16mm proximal from the distal tip.The balloon section was attached to the part of shaft that was detached.A visual examination identified that part of the balloon was detached.A complete balloon circumferential tear was identified located approximately 10mm distal of the proximal balloon sleeve.The proximal section of balloon material was also torn longitudinally beginning approximately 8mm distal of the proximal balloon sleeve and extending approximately 25mm distally across the balloon material.This type of damage most probably occurred when the device was being withdrawn through the sheath prior to a balloon rupture.A visual examination observed no damage to the tip of the device.A visual and tactile examination found the shaft of the device to have completely detached 16mm proximal from the distal tip.The shaft was also noted to be kinked and severely stretched.This type of damage is consistent with excessive tensile force being applied to the device.A visual examination found the proximal markerband to have completely detached from the device.The detached markerband was not returned for analysis.This concludes the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the mildly tortuous and non-calcified upper arm arteriovenous fistula.A 7.0 x 80, 75cm mustang balloon catheter was advanced for dilatation.However, during inflation at 12 atmospheres for 30 seconds, the balloon burst.The device was removed, and the procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient condition was normal.

• 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: 16588849
• Report Number: 2124215-2023-13313
• Device Sequence Number: 12194760
• Product Code: FGE
• UDI-Device Identifier: 08714729794264
• UDI-Public: 08714729794264
• 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): 05/17/2023

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: 12/12/2025
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0030700040
• 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: 03/15/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2022
• 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 Sex: Unknown