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

Model Number	80619
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter split in half.A direxion infusion catheter was selected for use in an embolization procedure.The catheter was introduced into the patient.However, it was noted that the catheter appeared damaged.It was removed, and upon inspection, it was found kinked and split in half.A new direxion infusion catheter was used to complete the procedure.There were no patient complications.
Event or Problem Description
It was reported that the catheter split in half.A direxion hi-flo infusion catheter was selected for use in an embolization procedure.The catheter was introduced into the patient.However, it was noted that the catheter appeared damaged.It was removed, and upon inspection, it was found kinked and split in half.A new direxion hi-flo was used to complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
Device eval by mfr: the direxion microcatheter was returned for analysis.The device shaft was visually and microscopically analyzed for any damage.The devices shaft showed a fracture located 8.8cm from the hub.The device was not completely separated the inner liner was still attached.No kinks were noticed.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

• Brand Name: DIREXION HI-FLO
• 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: 15993157
• Report Number: 2124215-2022-50572
• Device Sequence Number: 6089729
• Product Code: KRA
• UDI-Device Identifier: 08714729839484
• UDI-Public: 08714729839484
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2023

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: 11/23/2023
• Device Model Number: 80619
• Device Catalogue Number: 80619
• Device Lot Number: 0028436531
• 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: 11/23/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2021
• 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