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

Model Number	80618
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2022.It was reported that the micro catheter got kinked.The target lesion was located in the liver.A 155mm direxion catheter-infusion was selected for use.During the procedure, it was noted that the micro catheter got kinked upon super selection.The procedure was completed with a different device.No complications were reported, and patient was stable post procedure.However, device analysis revealed that the device was fractured 25.5cm from the hub.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device shaft was microscopically analyzed for any damage.The devices shaft showed 2 fractures located at the hub and 25.5cm from the hub.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The fractured shaft was confirmed.

• Brand Name: DIREXION
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15414931
• Report Number: 2134265-2022-08732
• Device Sequence Number: 6554344
• Product Code: KRA
• UDI-Device Identifier: 08714729839460
• UDI-Public: 08714729839460
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2022

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: 08/25/2023
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 0027905171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2021
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 60 KG