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

Model Number	24672
Medical Device Problem Codes	Defective Device (2588); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that balloon detachment occurred.A 6.0 x 150, 135cm mustang balloon catheter was advanced for dilation.However, during procedure, the balloon failed and came off the wire in the patient.No patient harm resulted in relation to this event.
Event or Problem Description
It was reported that balloon detachment occurred.A 6.0 x 150, 135cm mustang balloon catheter was advanced for dilation.However, during procedure, the balloon failed and came off the wire in the patient.No patient harm resulted in relation to this event.
Additional Manufacturer Narrative
This supplemental report was not able to be submitted on-time by boston scientific because of delayed acknowledgements from fda for the initial report.An fda system issue resulted in the delayed acknowledgements.This report will not be considered late, because it was the result of an fda system issue.B3 date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by manufacturer: mustang 6.0 x 150, 135cm was received for analysis.The device was received in two sections due to a complete separation of the shaft.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A visual examination found no issues with the balloon material.A balloon leak test could not be carried out due to severe shaft damage.As per mustang specification (#90519237) the rated burst pressure for this device is 22 atmospheres.No issues were noted with the tip section of the device.A visual examination found no damage or issues with the markerbands of the device.A visual and tactile examination found the shaft to have stretching damage and complete separation at a location just proximal of the proximal balloon.This type of damage is consistent with excessive tensile force being applied to 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; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16504219
• Report Number: 2124215-2023-07375
• Device Sequence Number: 6259413
• Product Code: LIT
• UDI-Device Identifier: 08714729793458
• UDI-Public: 08714729793458
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023

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: 10/30/2025
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0030456138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• 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