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

Model Number	80618
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter split.A 130 direxion catheter was selected for use in a hepatic artery chemoembolization procedure.During procedure, it was noted that the mid-section of the catheter ripped and split while delivering the chemo-agent.The device was removed, and the procedure was completed with another direxion.There were no patient complications and the patient was fine throughout.

• Brand Name: DIREXION
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10042846
• Report Number: 2134265-2020-06242
• Device Sequence Number: 16914500
• Product Code: KRA
• UDI-Device Identifier: 08714729839453
• UDI-Public: 08714729839453
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K142259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2020

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: 06/25/2021
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 0024014192
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1