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

Model Number	80618
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter coating detached.A 130cm direxion catheter was selected for an embolization procedure in the cheek hemangioma.During the procedure, the catheter coating detached.The catheter was completely removed by pulling out.A non-boston scientific catheter was used to successfully complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned device consisted of a direxion microcatheter.The device was bloody.Analysis of the tip, inner/outer shaft, and hub included visual and microscopic inspection.Inspection revealed the outer nickel shaft was separated 18.2 cm from the strain relief.The inner shaft was stretched and kinked at the outer shaft fracture faces.No other damage or defect was found with the returned device.
Event or Problem Description
It was reported that the catheter coating detached.A 130cm direxion catheter was selected for an embolization procedure in the cheek hemangioma.During the procedure, the catheter coating detached.The catheter was completely removed by pulling out.A non-boston scientific catheter was used to successfully complete the procedure.There were no patient complications.

• 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: 10943212
• Report Number: 2134265-2020-16918
• Device Sequence Number: 3230609
• Product Code: KRA
• UDI-Device Identifier: 08714729839385
• UDI-Public: 08714729839385
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 12/16/2020

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: 04/27/2022
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 0025473472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2020
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 12/16/2020
• Patient Sequence Number: 1