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

Model Number 84592

Device Problems Failure to Advance (2524); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 03/07/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event 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 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.

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
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9882722
• MDR Text Key: 185045754
• Report Number: 2134265-2020-03865
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729839644
• UDI-Public: 08714729839644
• Combination Product (y/n): N
• PMA/PMN Number: K142259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 81