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	02/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The (b)(4)% stenosed target lesion was located in mildly tortuous and mildly calcified radial arteriovenous fistula.A 7.0 x 80, 75cm mustang balloon catheter was advanced for dilatation.However, during initial inflation at rated burst pressure for 5 seconds, the balloon ruptured.The device was removed, and the procedure was completed with another of same device.There were no patient complications nor injuries were reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: mustang 7.0 x 80, 75cm was received for analysis.The device was received advance through the customers 7fr sheath.As device is compatible with a minimum of 5fr sheath.A visual examination identified that the balloon was not folded which indicates that it was subjected to positive pressure.A complete balloon circumferential tear were identified located approximately 10mm distal of the proximal balloon bond.From the circumferential tear, the distal section of balloon material was also torn longitudinally for approximately 20mm.No other issues were noted with the balloon material.Visual examination observed no damage to the tip of the device.A visual and tactile examination found the shaft of the device to be severely kinked and stretched at more than one location between the proximal and distal balloon bonds.This type of damage is consistent with excessive force being applied to the device.Both markerbands were present on the shaft of the device.Both proximal and distal markerbands were loose and had moved on the shaft of the device most probably due the damage to the shaft.
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in mildly tortuous and mildly calcified radial arteriovenous fistula.A 7.0 x 80, 75cm mustang balloon catheter was advanced for dilatation.However, during initial inflation at rated burst pressure for 5 seconds, the balloon ruptured.The device was removed, and the procedure was completed with another of same device.There were no patient complications nor injuries were reported and the patient was stable.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• 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: 16384938
• Report Number: 2124215-2023-06564
• Device Sequence Number: 5605463
• 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): 03/28/2023

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: 10/06/2025
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0030297517
• 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: 02/09/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2022
• 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