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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION HI-FLO; CATHETER, CONTINUOUS FLUSH
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BOSTON SCIENTIFIC CORPORATION DIREXION HI-FLO; CATHETER, CONTINUOUS FLUSH Back to Search Results
Model Number 80619
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
Additional Manufacturer Narrative
(b)(6).
 
Event or Problem Description
It was reported that a catheter was fractured.The target lesion was located in the very tortuous right buttocks artery.A direxion hi-flo was selected for use in an embolization procedure.During the procedure, it was noted that the catheter was broken about 50 cm in or about half way into the device.The device was able to be removed, but the system was lost.The procedure was successfully completed with a different device.No patient complications reported and no negative sequealae to the patient condition.
 
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Brand Name
DIREXION HI-FLO
Common Device Name
CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10043091
Report Number2134265-2020-06224
Device Sequence Number14223460
Product Code KRA
UDI-Device Identifier08714729839583
UDI-Public08714729839583
Combination Product (Y/N)N
Initial Reporter StateNM
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) 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 Date07/23/2020
Device Model Number80619
Device Catalogue Number80619
Device Lot Number0022417844
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/24/2020
Initial Report FDA Received Date05/11/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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