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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 05/15/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the device broke.The target lesion was located in the moderately tortuous splenic artery.A direxion hi-flo was selected for use.During procedure, it was noted that the outer shaft of the catheter broke and split into two at the area away from the hub.The device was removed per usual and no device piece were left inside patient's body.The procedure was completed with another of same device.No patient complications were reported and patient condition was good post procedure.
 
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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 Key10179796
Report Number2134265-2020-08271
Device Sequence Number3081723
Product Code KRA
UDI-Device Identifier08714729839545
UDI-Public08714729839545
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K142259
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/22/2020
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 Date06/27/2021
Device Model Number80619
Device Catalogue Number80619
Device Lot Number0024028998
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/04/2020
Initial Report FDA Received Date06/22/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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