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

Model Number	84590
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the microcatheter external sheath broke in two pieces.A direxion catheter was selected for use in a renal embolization procedure to treat a renal tumor.During the procedure, when entering the microcatheter, the external sheath was broken in two pieces.The problem was discovered because it was not possible to move the catheter forward.The microcatheter was removed out of the patient and the procedure was completed with an alternative method.There were no patient complications.
Event or Problem Description
It was reported that the microcatheter external sheath broke in two pieces.A direxion catheter was selected for use in a renal embolization procedure to treat a renal tumor.During the procedure, when entering the microcatheter, the external sheath was broken in two pieces.The problem was discovered because it was not possible to move the catheter forward.The microcatheter was removed out of the patient and the procedure was completed with an alternative method.There were no patient complications.
Additional Manufacturer Narrative
Device eval by mfr: the device was returned and analysis was completed.The returned product to consisted of a direxion microcatheter.Media was returned in the form of a photo.The photo was reviewed which showed the alleged separation and was confirmed during analysis.The hub, catheter shaft, and tip were visually examined for damage or any irregularities.Visual examination revealed that the catheter shaft showed a fracture of the outer shaft at 51.5 cm from the hub.A wire insertion test was not performed due to the extreme damage to the device.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

• Brand Name: DIREXION TRANSEND-14 SYSTEM
• 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: 18007166
• Report Number: 2124215-2023-58399
• Device Sequence Number: 7638075
• Product Code: KRA
• UDI-Device Identifier: 08714729839743
• UDI-Public: 08714729839743
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2023

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: 07/14/2024
• Device Model Number: 84590
• Device Catalogue Number: 84590
• Device Lot Number: 0029769166
• 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: 10/16/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2022
• 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