MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION HI-FLO FATHOM-16 SYSTEM; CATHETER, CONTINUOUS FLUSH

Model Number	84591
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the outer sheath separated.The non-stenosed target lesion was located in the mildly tortuous abdominal artery.A direxion hi-flo fathom-16 system was selected for use.During the introduction, the catheter was pulled back to reposition, however, the outer sheath separated.The device was pulled back from the sheath and was removed.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.

• Brand Name: DIREXION HI-FLO FATHOM-16 SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12054432
• Report Number: 2134265-2021-08011
• Device Sequence Number: 4423921
• Product Code: KRA
• UDI-Device Identifier: 08714729839712
• UDI-Public: 08714729839712
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K142259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2021

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: 09/17/2022
• Device Model Number: 84591
• Device Catalogue Number: 84591
• Device Lot Number: 0026031303
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1