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

Model Number	80618
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device tip ruptured.This direxion catheter was selected for use in a prostate embolization procedure with a non-boston scientific liquid embolization agent.During the procedure, the tip of the microcatheter remained embedded in the embolic agent, with the outer frame breaking off on attempted removal.Only the internal portion remained, stretching under traction until it broke off.The microcatheter ruptured in the 5f catheter and the fragment inside the patient was retrieved from outside the introducer.Further traction enabled the entire fragment to be removed completely.There were no patient consequences.
Additional Manufacturer Narrative
Device eval by manufacturer: the direxion microcatheter was returned to our post market quality assurance laboratory.Visual examination of the catheter shaft revealed a nickel shaft fracture; inner shaft stretching/tangled, and a complete shaft separation.Analysis of the returned device confirmed the clinical observations of shaft damage and a shaft separation.
Event or Problem Description
It was reported that the device tip ruptured.This direxion catheter was selected for use in a prostate embolization procedure with a non-boston scientific liquid embolization agent.During the procedure, the tip of the microcatheter remained embedded in the embolic agent, with the outer frame breaking off on attempted removal.Only the internal portion remained, stretching under traction until it broke off.The microcatheter ruptured in the 5f catheter and the fragment inside the patient was retrieved from outside the introducer.Further traction enabled the entire fragment to be removed completely.There were no patient consequences.

• 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 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: 18861193
• Report Number: 2124215-2024-13433
• Device Sequence Number: 3325395
• Product Code: KRA
• UDI-Device Identifier: 08714729839415
• UDI-Public: 08714729839415
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/22/2024

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: 01/15/2025
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 0030860538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO 5F INTRODUCER, TERUMO 5F SPINAL CATHETER; TERUMO 5F INTRODUCER, TERUMO 5F SPINAL CATHETER
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 93 KG