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

Model Number	80618
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the primary hepatic for treatment of liver cancer.A direxion catheter-infusion was selected for use.During the procedure, while inside the patient, the joint of the device was found fractured.The procedure was completed with another of the same device.No complications were reported.
Additional Manufacturer Narrative
E1 initial reporter facility name: the second affiliated hospital of (b)(6) medical university.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the primary hepatic for treatment of liver cancer.A direxion catheter-infusion was selected for use.During the procedure, while inside the patient, the joint of the device was found fractured.The procedure was completed with another of the same device.No complications were reported.It was further reported that the tail end plastic and metal joint was partially fractured at about 10cm upward towards the tip end.
Additional Manufacturer Narrative
E1 initial reporter facility name: (b)(6).Device evaluated by mfr.: the device was returned for analysis.Visual examination was performed, and an unknown guidewire was received stuck inside the device, which was soaked, but unable to be removed.There was no damage to either of the returned devices.X-ray inspection found no damage to either of the returned devices and verified both tips were undamaged and fully intact.Media showed the device was fractured; however, lab analysis was unable to confirm the alleged complaint issue.Inspection of the device revealed no damage or irregularities.The reported allegation was not confirmed for any shaft damage.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the primary hepatic for treatment of liver cancer.A direxion catheter-infusion was selected for use.During the procedure, while inside the patient, the joint of the device was found fractured.The procedure was completed with another of the same device.No complications were reported.It was further reported that the tail end plastic and metal joint was partially fractured at about 10cm upward towards the tip end.

• 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: 20041117
• Report Number: 2124215-2024-51371
• Device Sequence Number: 18153562
• 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): 10/04/2024

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: 10/01/2025
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 0032543583
• 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: 07/29/2024
• Supplement Date Received by Manufacturer: 08/18/2024; 09/10/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/09/2024; 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2023
• 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 Age: 69 YR
• Patient Sex: Female
• Patient Weight: 71 KG