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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 Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 07/17/2020
Event Type  malfunction  
Event Description
It was reported that the device was fractured.A 180cm/135cm renegade hi-flo fathom system was selected for use.Upon unpacking, it was noted that the device was fractured.The procedure was completed with another of the same device.There were no complications reported and the patient was stable.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The hub, shaft and tip were microscopically examined.The device showed three kinks located 9.5cm,46cm and 126cm from the hub.No fracture was noticed.Inspection of the remainder of the device apart from the observed damage, revealed no other damage or irregularities.
 
Event Description
It was reported that the device was fractured.A 180cm/135cm renegade hi-flo fathom system was selected for use.Upon unpacking, it was noted that the device was fractured.The procedure was completed with another of the same device.There were no complications reported and the patient was stable.
 
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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 Key10425347
MDR Text Key203488941
Report Number2134265-2020-11271
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 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/25/2022
Device Model Number29462
Device Catalogue Number29462
Device Lot Number0024170315
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2020
Date Manufacturer Received12/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age68 YR
Patient Weight70
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