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

Model Number	84590
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device separation occurred.A direxion transend-14 system was selected for use.Prior to the procedure, it was noted that the purple (proximal) part was separated from the rest of the microcatheter.The catheter was not used.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluation by manufacturer: the direxion microcatheter was returned to boston scientific for analysis.The device shaft was microscopically analyzed for any damage.The device showed a fracture located 2.2cm 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.The device was confirmed for a fractured shaft.
Event or Problem Description
It was reported that a device separation occurred.A direxion transend-14 system was selected for use.Prior to the procedure, it was noted that the purple (proximal) part was separated from the rest of the microcatheter.The catheter was not used.There were no patient complications reported.

• 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 CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16247689
• Report Number: 2124215-2023-02687
• Device Sequence Number: 17710355
• Product Code: KRA
• UDI-Device Identifier: 08714729839781
• UDI-Public: 08714729839781
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023

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: 07/18/2024
• Device Model Number: 84590
• Device Catalogue Number: 84590
• Device Lot Number: 0029789285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/02/2023
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2022
• 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