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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 Break (1069); Stretched (1601)
Patient Problem No Patient Involvement (2645)
Event Date 09/03/2020
Event Type  malfunction  
Event Description
It was reported that the catheter was broken.A 135/20 renegade hi-flo kit was selected for use.Prior preparing the device, it was noted that the catheter was broken and looks like it was stretched when tried to remove from the protective loop.The procedure was completed with another of the same device.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Analysis of the tip, inner/outer shaft, and hub/strain relief included microscopic and visual inspection.Inspection revealed a fracture in the outer shaft located 1.1cm from the strain relief with outer shaft stretched, and the inner shaft was stretched between the outer shaft fracture faces.Inspection of the rest of the device found no other damage or defect.
 
Event Description
It was reported that the catheter was broken.A 135/20 renegade hi-flo kit was selected for use.Prior preparing the device, it was noted that the catheter was broken and looks like it was stretched when tried to remove from the protective loop.The procedure was completed with another of the same device.There were no patient complications reported.
 
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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 Key10600739
MDR Text Key208988049
Report Number2134265-2020-13411
Device Sequence Number1
Product Code KRA
UDI-Device Identifier08714729280781
UDI-Public08714729280781
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,health
Type of Report Initial,Followup
Report Date 10/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/21/2022
Device Model Number29460
Device Catalogue Number29460
Device Lot Number0025242917
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2020
Date Manufacturer Received10/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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