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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION; CATHETER, CONTINUOUS FLUSH
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BOSTON SCIENTIFIC CORPORATION DIREXION; CATHETER, CONTINUOUS FLUSH Back to Search Results
Model Number 80618
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/06/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the catheter was broken.The target lesion was located in the moderately tortuous right hepatic artery.A direxion microcatheter was selected for use.During procedure, the device was used in tracking through anatomy and continuous saline flush was maintained.However, it was noted that the nitinol hypotube broke in the center of the catheter.The device was remove completely with the transcend guidewire within it and the procedure was completed with another of the same device.No patient complications were reported and patient was fine post procedure.
 
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Brand Name
DIREXION
Common Device Name
CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9987006
Report Number2134265-2020-05406
Device Sequence Number3896349
Product Code KRA
UDI-Device Identifier08714729839354
UDI-Public08714729839354
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K142259
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/22/2020
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 Date11/25/2020
Device Model Number80618
Device Catalogue Number80618
Device Lot Number0022988712
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/06/2020
Initial Report FDA Received Date04/22/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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