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	04/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the microcatheter was broken.This direxion fathom-16 system microcatheter was selected for use, and during the procedure the contrast was observed from where the microcatheter was broken.The microcatheter was removed, and the procedure was completed with a new direxion microcatheter.No patient complications.
Additional Manufacturer Narrative
Device eval by manufacturer: the direxion fathom-16 system microcatheter was received for analysis.Microscopic examination of the shaft showed a fracture located 4.8 cm from the hub.The device was not completely separated the inner liner was still attached.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.A fractured shaft was confirmed.
Event or Problem Description
It was reported that the microcatheter was broken.This direxion fathom-16 system microcatheter was selected for use, and during the procedure the contrast was observed from where the microcatheter was broken.The microcatheter was removed, and the procedure was completed with a new direxion microcatheter.No patient complications.Additional information was received indicating that the break occurred at the proximal end of the catheter when making a series of pumps via the catheter in the right hepatic artery.There was no resistance experienced, and the anatomical conditions were normal.
Event or Problem Description
It was reported that the microcatheter was broken.This direxion fathom-16 system microcatheter was selected for use, and during the procedure the contrast was observed from where the microcatheter was broken.The microcatheter was removed, and the procedure was completed with a new direxion microcatheter.No patient complications.Additional information was received indicating that the break occurred at the proximal end of the catheter when making a series of pumps via the catheter in the right hepatic artery.There was no resistance experienced, and the anatomical conditions were normal.

• 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 ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16773902
• Report Number: 2124215-2023-18837
• Device Sequence Number: 12439774
• Product Code: KRA
• UDI-Device Identifier: 08714729839651
• UDI-Public: 08714729839651
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2023

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: 11/22/2024
• Device Model Number: 84592
• Device Catalogue Number: 84592
• Device Lot Number: 0030593268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 04/19/2023; 05/16/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/15/2023; 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown