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	09/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.
Event or Problem Description
It was reported that tip detachment occurred.A direxion catheter was selected for use in the liver.During the procedure, it was noted that the tip of the device fractured.The procedure was completed with a different device.No complications were reported and the patient was stable post procedure.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.Device evaluated by mfr: the device was returned for evaluation.Visual and microscope inspections were performed.Shaft fracture and separation at hub were noted and there was no damage to tip.No other issues were identified with the device and no patient complications were reported.
Event or Problem Description
It was reported that tip detachment occurred.A direxion catheter was selected for use in the liver.During the procedure, it was noted that the tip of the device fractured.The procedure was completed with a different device.No complications were reported, and the patient was stable post procedure.

• 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: 20523134
• Report Number: 2124215-2024-65003
• Device Sequence Number: 7969362
• Product Code: KRA
• UDI-Device Identifier: 08714729839354
• UDI-Public: 08714729839354
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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: 01/09/2026
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 0033183816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• 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: Female