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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE HI-FLO FATHOM SYSTEM; CATHETER, CONTINUOUS FLUSH
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BOSTON SCIENTIFIC CORPORATION RENEGADE HI-FLO FATHOM SYSTEM; CATHETER, CONTINUOUS FLUSH Back to Search Results
Model Number 29462
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/26/2021
Event Type  malfunction  
Event Description
It was reported that there was irregular hairiness.A 180cm/135cm renegade hi-flo fathom system was selected for use.During the procedure, it was noted that there was irregular hairiness at the tip of the microcatheter when it was flushed.The procedure was completed with another of the same device.There were no complications reported and patient was stable post procedure.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device returned with a guidewire in the lumen.The device was inspected for any damage or irregularities.The renegade shaft and tip were microscopically examined for any foreign material present.There was no indication of any foreign material on the shaft or tip.The renegade showed damage in the form of flattened areas along the distal part of the shaft located 126cm from the hub to the tip.The renegade showed a coating build up approximately 125cm from the hub.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint for foreign material was not confirmed; however, shaft damage was confirmed.
 
Event Description
It was reported that there was irregular hairiness.A 180cm/135cm renegade hi-flo fathom system was selected for use.During the procedure, it was noted that there was irregular hairiness at the tip of the microcatheter when it was flushed.The procedure was completed with another of the same device.There were no complications reported and patient was stable post procedure.
 
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Brand Name
RENEGADE HI-FLO FATHOM SYSTEM
Type of Device
CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12485789
MDR Text Key271889599
Report Number2134265-2021-11689
Device Sequence Number1
Product Code KRA
UDI-Device Identifier08714729790853
UDI-Public08714729790853
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 10/21/2021
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
Device Operator Health Professional
Device Expiration Date12/14/2023
Device Model Number29462
Device Catalogue Number29462
Device Lot Number0026512927
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2021
Initial Date Manufacturer Received 08/27/2021
Initial Date FDA Received09/16/2021
Supplement Dates Manufacturer Received09/30/2021
Supplement Dates FDA Received10/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age60 YR
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