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	07/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter facility name: (b)(6).E1.Initial reporter address 1:(b)(6).
Event or Problem Description
It was reported that a device fracture occurred.The target lesion was located in the liver.A direxion was selected for use.During the procedure, it was noted that the device was fractured approximately 90cm from the hub.The device was removed from the patient's body normally and the procedure was completed with another with another direxion.There were no complications reported and the patient was stable post procedure.
Additional Manufacturer Narrative
E1.Initial reporter facility name: (b)(6).E1.Initial reporter address 1: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The device shaft was visually and microscopically analyzed for any damage.The device showed a kink located 122.5cm from the hub.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.A kinked shaft was confirmed.
Event or Problem Description
It was reported that a device fracture occurred.The target lesion was located in the liver.A direxion was selected for use.During the procedure, it was noted that the device was fractured approximately 90cm from the hub.The device was removed from the patient's body normally and the procedure was completed with another with another direxion.There were no complications 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 CORK LIMITED; 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: 17493039
• Report Number: 2124215-2023-40699
• Device Sequence Number: 17953602
• 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): 09/20/2023

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: 11/30/2024
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 0030631133
• 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: 07/17/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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: 40 YR
• Patient Sex: Female
• Patient Weight: 54 KG