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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 Material Integrity Problem (2978)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/01/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Date of event: used (b)(6) 2021 as the event date was not reported.
 
Event or Problem Description
It was reported that the catheter was peeling off.A 130cm direxion infusion catheter was selected for use.During the procedure, it was noted that the outside layer of the catheter started peeling off as it went through the gateway plus y-adapter.The catheter was removed and a different microcatheter was used to complete the procedure.No harm to the patient was reported.
 
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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 Key12555066
Report Number2134265-2021-12280
Device Sequence Number3487475
Product Code KRA
UDI-Device Identifier08714729839323
UDI-Public08714729839323
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
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 09/30/2021
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 Date05/04/2023
Device Model Number80618
Device Catalogue Number80618
Device Lot Number0027252076
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/09/2021
Initial Report FDA Received Date09/30/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
Y-ADAPTER - GATEWAY PLUS
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