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

Model Number	84592
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the device was fractured upon removal.The target lesion was located in the severely tortuous and moderately calcified artery in the knee area.A direxion fathom-16 system was selected for use.During the procedure, both non boston scientific guidewire and the catheter became very jumbled up.The device was hydrated prior to removal of the device.When the device was removed completely, it was noted that the catheter was broken 3 inches from the tip of the device.No patient complications were reported.
Event or Problem Description
It was reported that the device was fractured upon removal.The target lesion was located in the severely tortuous and moderately calcified artery in the knee area.A direxion fathom-16 system was selected for use.During the procedure, both non boston scientific guidewire and the catheter became very jumbled up.The device was hydrated prior to removal of the device.When the device was removed completely, it was noted that the catheter was broken 3 inches from the tip of the device.No patient complications were reported.
Additional Manufacturer Narrative
E1- initial reporter address 1: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The device shaft was analyzed for any damage.The devices nickel shaft showed damage in the form of a fracture located 126cm from the hub.The fracture looked to be consistent with a tensile force breaking as the device was not completely separated, the inner liner was still attached.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• Brand Name: DIREXION FATHOM-16 SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13384683
• Report Number: 2134265-2022-00348
• Device Sequence Number: 14372481
• Product Code: KRA
• UDI-Device Identifier: 08714729839637
• UDI-Public: 08714729839637
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2022

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: 10/27/2023
• Device Model Number: 84592
• Device Catalogue Number: 84592
• Device Lot Number: 0028275601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/06/2022
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2021
• 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: Male