MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION TRANSEND-14 SYSTEM; CATHETER, CONTINUOUS FLUSH

Model Number	84590
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device shaft was visually and microscopically analyzed for any damage.The devices shaft showed a fracture located 40.5cm from the hub.The device was not completely separated, the inner liner was still attached.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.This device met the manufacturing specification.
Event or Problem Description
Reportable based on device analysis completed on 13dec2022.It was reported that the device was kinked.The target lesion was located in the mildly tortuous vessel.A direxion catheter infusion was selected for use.During the procedure, when introducing the direxion through 5f catheter, it was difficult to be pushed forward.Consequently, the device was removed and found it was kinked.The procedure was completed with another of the same device.There were no patient complications reported.However, device analysis revealed that the shaft was fractured approx.40.5cm from the hub.

• Brand Name: DIREXION TRANSEND-14 SYSTEM
• 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: 16099248
• Report Number: 2124215-2022-53288
• Device Sequence Number: 17818558
• Product Code: KRA
• UDI-Device Identifier: 08714729839774
• UDI-Public: 08714729839774
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 01/04/2023

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: 06/23/2024
• Device Model Number: 84590
• Device Catalogue Number: 84590
• Device Lot Number: 0029649405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2022
• 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 Sex: Unknown