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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE HI-FLO; CATHETER, CONTINUOUS FLUSH
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BOSTON SCIENTIFIC CORPORATION RENEGADE HI-FLO; CATHETER, CONTINUOUS FLUSH Back to Search Results
Model Number 29420
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/01/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that a catheter break occurred.A 150/10 renegade hi-flo catheter infusion was selected for use for a uterine fibroid embolization procedure.During the procedure, it was noted that the renegade felt a bit tight on the 4fr non bsc guide catheter.The physician was able to complete the intervention; however, during removal of the catheter, it was noted that further tightness was experienced and the renegade began to break and unravel.The device was completely removed with the non bsc guide catheter from the patient's body.No patient complications were reported.
 
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Brand Name
RENEGADE HI-FLO
Common Device Name
CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8632590
Report Number2134265-2019-05573
Device Sequence Number2353719
Product Code KRA
UDI-Device Identifier08714729280651
UDI-Public08714729280651
Combination Product (Y/N)N
Initial Reporter StateOR
Initial Reporter CountryUS
PMA/510(K) Number
K140329
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) 05/22/2019
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 Date11/16/2021
Device Model Number29420
Device Catalogue Number29420
Device Lot Number0023095318
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/01/2019
Initial Report FDA Received Date05/22/2019
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
GUIDE CATHETER: TERUMO GLIDE BERN (4FRX120)
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