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

Model Number	84592
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the core wire fractured.A direxion infusion catheter kit supplied with a fathom guidewire was selected for use.During use, it was noted that the last few fathom guidewires supplied in the direxion catheter kit lost their shape quickly, even during the first reconfiguration.In one fathom guidewire, it resulted a fracture of the core wire.The procedure was completed with a new device, same model.There were no patient complications.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).D4 - lot number: updated.
Event or Problem Description
It was reported that the core wire fractured.A direxion infusion catheter kit supplied with a fathom guidewire was selected for use.During use, it was noted that the last few fathom guidewires supplied in the direxion catheter kit lost their shape quickly, even during the first reconfiguration.In one fathom guidewire, it resulted a fracture of the core wire.The procedure was completed with a new device, same model.There were no patient complications.

• 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: 20101444
• Report Number: 2124215-2024-50878
• Device Sequence Number: 12730186
• Product Code: KRA
• UDI-Device Identifier: 08714729839606
• UDI-Public: 08714729839606
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

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: 05/03/2026
• Device Model Number: 84592
• Device Catalogue Number: 84592
• Device Lot Number: 0033957508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 09/18/2024
• Date Device Manufactured: 05/03/2024
• 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