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

Model Number	24674
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.
Event or Problem Description
It was reported that contamination occurred.The target lesion was located in the iliac artery.A 9.0 x 40, 135cm mustang balloon catheter was selected for use.During unpacking, it was noted that the sterile package had been damaged.The device was not used, and the procedure was completed with a different device.No complications were reported, and the patient was stable post procedure.
Event or Problem Description
It was reported that contamination occurred.The target lesion was located in the iliac artery.A 9.0 x 40, 135cm mustang balloon catheter was selected for use.During unpacking, it was noted that the sterile package had been damaged.The device was not used, and the procedure was completed with a different device.No complications were reported, and the patient was stable post procedure.It was further reported that the sterile pouch was already damaged upon unpacking the external package.This compromised the sterility of the device.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.Device eval by manufacturer: the device was returned for analysis.The outer box was noted to be opened, and the blue seal was also noted to be unfastened.The outer box was noted to be damaged.The inner pouch was found to be opened.The device was still in its coil and appeared to be unused.

• 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: 20158971
• Report Number: 2124215-2024-55834
• Device Sequence Number: 20897792
• Product Code: FGE
• UDI-Device Identifier: 08714729794134
• UDI-Public: 08714729794134
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2024

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: 05/23/2025
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0029458183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• 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: Female