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

Model Number	84592
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the microcatheter was fractured.The target lesion was located in the moderately tortuous and non-calcified vessel.A direxion fathom-16 system was selected for use in an ovarian vein embolization procedure to treat pelvic congestion syndrome.During the procedure, it was noted that resistance was felt during coil deployment.The whole microcatheter was removed and a fracture was found halfway down the microcatheter.The fractured portion was in the sheath.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The device shaft was visually and microscopically analyzed for any damage.The device showed a fracture located 59.4cm from the hub.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 microcatheter was fractured.The target lesion was located in the moderately tortuous and non-calcified vessel.A direxion fathom-16 system was selected for use in an ovarian vein embolization procedure to treat pelvic congestion syndrome.During the procedure, it was noted that resistance was felt during coil deployment.The whole microcatheter was removed and a fracture was found halfway down the microcatheter.The fractured portion was in the sheath.The procedure was completed with another of the same device.No patient complications were reported.

• 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: 18041584
• Report Number: 2124215-2023-59626
• Device Sequence Number: 7499922
• Product Code: KRA
• UDI-Device Identifier: 08714729839606
• UDI-Public: 08714729839606
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 12/15/2023

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: 07/30/2025
• Device Model Number: 84592
• Device Catalogue Number: 84592
• Device Lot Number: 0032116215
• 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: 10/18/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2023
• 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