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	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used (b)(6) 2021 as the event date was not reported.
Event or Problem Description
It was reported that the microcatheter broke.A direxion fathom-16 system was selected for use in a coiling procedure.During the procedure, it was noted that the device broke in the middle of coiling.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
B3 - date of event: used (b)(6) 2021 as the event date was not reported.Device evaluated by mfr: the direxion microcatheter was returned to boston scientific for analysis.The device shaft was analyzed for any damage.The device shaft showed 1 fracture located 59cm from the hub.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.A fracture was confirmed.
Event or Problem Description
It was reported that the microcatheter broke.A direxion fathom-16 system was selected for use in a coiling procedure.During the procedure, it was noted that the device broke in the middle of coiling.The procedure was completed with a different device.No patient complications were reported.

• 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: 12749234
• Report Number: 2134265-2021-13778
• Device Sequence Number: 4647901
• Product Code: KRA
• UDI-Device Identifier: 08714729839613
• UDI-Public: 08714729839613
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

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: 07/21/2023
• Device Model Number: 84592
• Device Catalogue Number: 84592
• Device Lot Number: 0027706107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/13/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2021
• 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: Unknown