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

Model Number 84591

Device Problems Break (1069); Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2020

Event Type  malfunction  

Event Description

It was reported that removal difficulty occurred.A direxion hi-flo fathom-16 system was selected for use in a y90 mapping procedure.A radial access approach was used.During procedure, upon advancement of the direxion microcatheter thru the non-bsc diagnostic catheter, the physician noted that resistance was met within the base catheter due to the tortuous anatomy.The direxion fractured at the hub and was difficult to remove.The entire system was removed intact.The procedure was completed with another of the same device.No patient complications reported.

Manufacturer Narrative

Device evaluated by manufacturer.Returned product consisted of a direxion hi flo microcatheter with the guide wire in the shaft with a y-connector.The guide wire could not be separated from the catheter.Analysis of the tip, inner/outer shaft, and hub/strain relief included microscopic and visual inspection.Inspection revealed a complete separation of the outer shaft located 34.3 cm from the strain relief with the inner shaft stretched taught in between the separation and over the wire.Inspection of the rest of the device found no other damage or defect.The reported catheter fracture and difficulty removing were confirmed, however, the friction could not be confirmed as clinical circumstances could not be replicated.

Event Description

It was reported that removal difficulty occurred.A direxion hi-flo fathom-16 system was selected for use in a y90 mapping procedure.A radial access approach was used.During procedure, upon advancement of the direxion microcatheter thru the non-bsc diagnostic catheter, the physician noted that resistance was met within the base catheter due to the tortuous anatomy.The direxion fractured at the hub and was difficult to remove.The entire system was removed intact.The procedure was completed with another of the same device.No patient complications reported.

• Brand Name: DIREXION HI-FLO 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: 10138668
• MDR Text Key: 194661161
• Report Number: 2134265-2020-07774
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729839729
• UDI-Public: 08714729839729
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/17/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2022
• Device Model Number: 84591
• Device Catalogue Number: 84591
• Device Lot Number: 0025373035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/10/2020
• Supplement Dates Manufacturer Received: 07/09/2020
• Supplement Dates FDA Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DIAGNOSTIC CATHETER: TERUMO 5FR SARAH; DIAGNOSTIC CATHETER: TERUMO 5FR SARAH; DIAGNOSTIC CATHETER: TERUMO 5FR SARAH
• Patient Age: 81 YR