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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE HI-FLO KIT; CATHETER, CONTINUOUS FLUSH
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BOSTON SCIENTIFIC CORPORATION RENEGADE HI-FLO KIT; CATHETER, CONTINUOUS FLUSH Back to Search Results
Model Number 29460
Device Problems Fracture (1260); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/20/2020
Event Type  malfunction  
Event Description
It was reported that the device was fractured.The target lesion was located in the gastroduodenal artery.A 135/10 renegade hi-flo kit was selected for use.During procedure, it was noted that the microcatheter was fractured and the guidewire could not cross successfully.The device was simply removed from the patient's body and the procedure was completed with another of the same device.No complications reported and the patient is stable.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a renegade hi-flo microcatheter with a y-connector and a guide wire.The device was bloody.Analysis of the tip, inner/outer shaft, and hub/strain relief included microscopic and visual inspection.Inspection revealed numerous kinks throughout the shaft.Inspection of the rest of the device found no other damage or defect.The renegade device was tested with the guide wire that was returned with the device.The tip of the guide wire was loaded into the hub of the renegade and advanced through the shaft.The guide wire advanced, although there was some resistance when the wire encountered the kinked areas.
 
Event Description
It was reported that the device was fractured.The target lesion was located in the gastroduodenal artery.A 135/10 renegade hi-flo kit was selected for use.During procedure, it was noted that the microcatheter was fractured and the guidewire could not cross successfully.The device was simply removed from the patient's body and the procedure was completed with another of the same device.No complications reported and the patient is stable.
 
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Brand Name
RENEGADE HI-FLO KIT
Type of Device
CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10234229
MDR Text Key197647685
Report Number2134265-2020-08902
Device Sequence Number1
Product Code KRA
UDI-Device Identifier08714729280774
UDI-Public08714729280774
Combination Product (y/n)N
PMA/PMN Number
K140329
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 08/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/28/2021
Device Model Number29460
Device Catalogue Number29460
Device Lot Number0024028987
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2020
Date Manufacturer Received07/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age62 YR
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