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

Model Number	80618
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that catheter fracture occurred.A direxion microcatheter was selected for use perform angiography of vessel.During the procedure, it was noted that the microcatheter was fractured.The procedure was completed with another device.No complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).The device was returned for analysis, and the evaluation was completed on 04nov2024.The device was examined visually, and it was found that there was a fracture in the nickel shaft located approximately 48.5cm from the strain relief.The inner lumen was still intact.There was no damage observed to the microcatheter shaft 2-3cm from the microcatheter hub.The reported event of a fractured shaft was confirmed, but not in the location that was reported.
Event or Problem Description
It was reported that catheter fracture occurred.A direxion microcatheter was selected for use perform angiography of vessel.During the procedure, it was noted that the microcatheter was fractured.The procedure was completed with another device.No complications were reported, and the patient was stable post procedure.It was further reported that the fracture was noted on the connector 2-3cm from the hub.The inner lumen and nickel shaft were not intact.

• 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: 20216267
• Report Number: 2124215-2024-55992
• Device Sequence Number: 8151867
• Product Code: KRA
• UDI-Device Identifier: 08714729839439
• UDI-Public: 08714729839439
• 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): 11/05/2024

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: 04/04/2025
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 0031374960
• 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: 08/20/2024
• Supplement Date Received by Manufacturer: 10/13/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2023
• 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: Female