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

Model Number	80618
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that catheter detachment occurred.A direxion catheter infusion was selected for use.During the procedure, it was noted that the microcatheter was separated in the vessel.The microcatheter was completely removed via snaring and the procedure was completed with another of the same device.No complications were reported, and the patient was not harmed.
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 54.4cm from the hub.The device was not completely separated, the inner liner was still attached.There was not a complete separation of the device.The device showed a fracture only.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.A fractured shaft was confirmed.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that catheter detachment occurred.A direxion catheter infusion was selected for use.During the procedure, it was noted that the microcatheter was separated in the vessel.The microcatheter was completely removed via snaring and the procedure was completed with another of the same device.No complications were reported, and the patient was not harmed.

• Brand Name: DIREXION
• 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: 18349353
• Report Number: 2124215-2023-70987
• Device Sequence Number: 6212201
• Product Code: KRA
• UDI-Device Identifier: 08714729839330
• UDI-Public: 08714729839330
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/06/2025
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 0031963338
• 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: 12/08/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male