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

Model Number	84591
Medical Device Problem Codes	Break (1069); Defective Device (2588); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter was fractured.A direxion hi-flo fathom-16 system was selected for use.During the procedure, advancement of coils was difficult due to microcatheter stretching towards microcatheter tip.It was noted that the catheter fractured during attempted advancement and withdrawal, within the base catheter, with just mild to moderate force.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The device shaft was microscopically analyzed for any damage.The guidewire was stuck in the device.The device showed a fractured shaft located 40.2cm from the hub.The device was not completely separated, the inner liner was still intact.The inner liner was stretched and constricting the guidewire from movement.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the catheter was fractured.A direxion hi-flo fathom-16 system was selected for use.During the procedure, advancement of coils was difficult due to microcatheter stretching towards microcatheter tip.It was noted that the catheter fractured during attempted advancement and withdrawal within base catheter with just mild to moderate force.The procedure was completed with a different device.No patient complications were reported.

• Brand Name: DIREXION HI-FLO FATHOM-16 SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16259087
• Report Number: 2124215-2023-01423
• Device Sequence Number: 4881155
• Product Code: KRA
• UDI-Device Identifier: 08714729839712
• UDI-Public: 08714729839712
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 02/23/2023

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: 01/21/2024
• Device Model Number: 84591
• Device Catalogue Number: 84591
• Device Lot Number: 0028721418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/04/2023
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2022
• 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: Male