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

Model Number	24674
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device contamination occurred.The 99% stenosed target lesion was located in the mildly tortuous and mildly calcified iliac artery.A 8.0 x 20, 75cm mustang balloon catheter was selected for use.However, when the device was opened during preparation, a small piece of foreign material was noted inside the inner pouch compromising the sterility of the device.It was noted that the inner pouch of the package was intact.The procedure was completed with another of same device.No patient injury was reported.
Event or Problem Description
It was reported that device contamination occurred.The 99% stenosed target lesion was located in the mildly tortuous and mildly calcified iliac artery.A 8.0 x 20, 75cm mustang balloon catheter was selected for use.However, when the device was opened during preparation, a small piece of foreign material was noted inside the inner pouch compromising the sterility of the device.It was noted that the inner pouch of the package was intact.The procedure was completed with another of same device.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: a mustang device was returned for analysis.The device was received in the inner packaging, which was opened.No foreign material was noted on the device or packaging.No issues noted with device.

• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12711410
• Report Number: 2134265-2021-13086
• Device Sequence Number: 4703537
• Product Code: FGE
• UDI-Device Identifier: 08714729793519
• UDI-Public: 08714729793519
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/02/2021

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: 02/26/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0023412444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2019
• 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