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

Model Number	84592
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that internal catheter break occurred.The non- stenosed target lesion was located in the mildly tortuous and non-calcified left knee vessel.A 021/bern/2ro/130 direxion catheter infusion was selected for use.During the embolization procedure, the catheter felt obstructed and was no longer delivering any beads.Upon removal of the microcatheter, it was observed that the catheter was broken along the shaft and twisted, 6-7 inches distal to the hub.The procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that internal catheter break occurred.The non- stenosed target lesion was located in the mildly tortuous and non-calcified left knee vessel.A 021/bern/2ro/130 direxion catheter infusion was selected for use.During the embolization procedure, the catheter felt obstructed and was no longer delivering any beads.Upon removal of the microcatheter, it was observed that the catheter was broken along the shaft and twisted, 6-7 inches distal to the hub.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Inspection of the device revealed a nickel shaft fracture and stretching.Shaft kinks were also observed.Inspection of the device revealed a nickel shaft fracture located at 13.5 cm and a nickel shaft fracture/stretching located at 18.6 cm to 20 cm from the strain relief.Shaft kinks were observed at 18.6 cm, 19.2 cm and 19.8 cm from the strain relief.

• Brand Name: DIREXION FATHOM-16 SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20349015
• Report Number: 2124215-2024-59210
• Device Sequence Number: 8108100
• Product Code: KRA
• UDI-Device Identifier: 08714729839668
• UDI-Public: 08714729839668
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 11/05/2024

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: 02/16/2026
• Device Model Number: 84592
• Device Catalogue Number: 84592
• Device Lot Number: 0034346473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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