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	05/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a fracture occurred.A direxion microcatheter was selected for use.The lesion was accessed through the femoral artery in the right groin and the device was advanced to the target lesion.During removal of the microcatheter, an abnormality was observed near the tip of the device.There was a split at the tip and it looked damaged and worn out.The procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that a fracture occurred.A direxion microcatheter was selected for use.The lesion was accessed through the femoral artery in the right groin and the device was advanced to the target lesion.During removal of the microcatheter, an abnormality was observed near the tip of the device.There was a split at the tip and it looked damaged and worn out.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the direxion microcatheter was returned for analysis.The device shaft was microscopically analyzed for any damage.The device showed a fracture at the hub.There were also 2 other fractures located 70.2cm and 70.5cm from the hub.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

• Brand Name: DIREXION 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 CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14877579
• Report Number: 2134265-2022-07510
• Device Sequence Number: 17398965
• Product Code: KRA
• UDI-Device Identifier: 08714729839637
• UDI-Public: 08714729839637
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

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: 09/02/2023
• Device Model Number: 84592
• Device Catalogue Number: 84592
• Device Lot Number: 0027955416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown