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

Model Number	M001195240
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter fractured occurred.The target lesion was located in the lower gastrointestinal.A direxion catheter-infusion was selected for use.During the procedure, the catheter was found fractured.The procedure was completed with another of the same device.No complications were reported, and the patient condition following procedure was stable.
Event or Problem Description
It was reported that catheter fractured occurred.The target lesion was located in the lower gastrointestinal.A direxion catheter-infusion was selected for use.During the procedure, the catheter was found fractured.The procedure was completed with another of the same device.No complications were reported, and the patient condition following procedure was stable.It was further reported that the target lesion was mildly tortuous and mildly calcified.The middle part of the catheter was fractured and was pulled out without any intervention during removal.The device was not entirely detached.
Event or Problem Description
It was reported that catheter fractured occurred.The target lesion was located in the lower gastrointestinal.A direxion catheter-infusion was selected for use.During the procedure, the catheter was found fractured.The procedure was completed with another of the same device.No complications were reported, and the patient condition following procedure was stable.It was further reported that the target lesion was mildly tortuous and mildly calcified.The middle part of the catheter was fractured and was pulled out without any intervention during removal.The device was not entirely detached.
Additional Manufacturer Narrative
Device evaluation by manufacturer: upon receipt at our post market quality assurance laboratory, the device was inspected microscopically to reveal nickel shaft fractures at approximately 11.5cm, 41.5cm, and 51cm from the strain relief.The device was inspected with x-ray imaging to revealed occlusion in shaft.The occluded shaft failed to cross over a 0.18 inch guidewire.

• 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: 20980914
• Report Number: 2124215-2024-79949
• Device Sequence Number: 8447740
• 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,Followup
• Report Date (Section B): 03/03/2025

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: 01/30/2026
• Device Model Number: M001195240
• Device Catalogue Number: M001195240
• Device Lot Number: 0033323454
• 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: 12/09/2024
• Supplement Date Received by Manufacturer: 01/05/2025; 02/07/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 01/27/2025; 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 67 KG