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

Model Number	80618
Medical Device Problem Codes	Entrapment of Device (1212); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coating of direxion was separated/broken.A direxion catheter-infusion was selected for use.During procedure, the microcatheter started to drag and became stuck inside 4fr access catheter.Physician suspected that the coating has separated/broken.The procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The device was stuck inside a merit 4fr.038 internal diameter access catheter.The hub end of the direxion was protruding from the proximal end of the access catheter approximately 18cm from the hub.The distal end of the direxion was protruding from the access catheter distal end approximately 19cm.The outside diameter on the direxion was checked and measured.0345 which is per the product specification.There were multiple bends and kinks throughout the length of the device.There was a severe kink on the access catheter approximately 73cm from the hub of the access catheter.With the device stuck in the access catheter.The coating issue could not be confirmed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
Event or Problem Description
It was reported that the coating of direxion was separated/broken.A direxion catheter-infusion was selected for use.During procedure, the microcatheter started to drag and became stuck inside 4fr access catheter."physician" suspected that the coating has separated/broken.The procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.

• 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: 11971070
• Report Number: 2134265-2021-07028
• Device Sequence Number: 19956247
• Product Code: KRA
• UDI-Device Identifier: 08714729839361
• UDI-Public: 08714729839361
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021

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: 01/29/2023
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 0026718063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1