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

Model Number	84592
Medical Device Problem Codes	Failure to Advance (2524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the tip of the guidewire fractured.A 155cm direxion fathom-16 system was selected for use.During preparation, resistance was noted upon removing the fathom guidewire from the catheter and upon inserting it again.However, the tip of the guidewire was noted to be fractured upon removal.The procedure was completed with the same device.No patient complications reported.
Event or Problem Description
It was reported that the tip of the guidewire fractured.A 155cm direxion fathom-16 system was selected for use.During preparation, resistance was noted upon removing the fathom guidewire from the catheter and upon inserting it again.However, the tip of the guidewire was noted to be fractured upon removal.The procedure was completed with the same device.No patient complications reported.
Additional Manufacturer Narrative
Initial reporter city: (b)(6).Device evaluated by manufacturer: returned product consisted of a renegade hi flo microcatheter and the guide wire.Analysis of the guide wire, tip, sheath, and hub included microscopic and visual inspection.Inspection found no damage or defect to the direxion microcatheter or the guide wire.The direxion and guide wire interaction test showed that the direxion was hydrated and the tip of the guide wire was loaded into the hub of the direxion.The wire was advanced easily and smoothly through the microcatheter, without any resistance.

• 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
• MDR Report Key: 9882722
• Report Number: 2134265-2020-03865
• Device Sequence Number: 2794664
• Product Code: KRA
• UDI-Device Identifier: 08714729839644
• UDI-Public: 08714729839644
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K142259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2020

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: 07/28/2021
• Device Model Number: 84592
• Device Catalogue Number: 84592
• Device Lot Number: 0024178069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Initial Date Received by Manufacturer: 03/07/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 81