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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); Difficult to Open or Remove Packaging Material (2922); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2021
Event Type  malfunction  
Event Description
It was reported that a catheter break occurred.During unpacking of a renegade hi-flo kit, the catheter could not be removed from the packaging loop.The catheter and packaging loop were rinsed with water in an effort to remove the catheter; however, the catheter broke.The procedure was completed successfully and no patient complications occurred.
 
Manufacturer Narrative
H3 - device evaluated by manufacturer: the renegade hi-flo microcatheter was returned to boston scientific for analysis.The device was partially in the shipping tube when returned.The device showed damage in the form of stretching and a fracture located 1.5cm from the hub.It was also stretched and kinked 9cm from the hub.The device was not completely separated, the inner liner was still attached.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The device was confirmed for shaft stretching and fractures.
 
Event Description
It was reported that a catheter break occurred.During unpacking of a renegade hi-flo kit, the catheter could not be removed from the packaging loop.The catheter and packaging loop were rinsed with water in an effort to remove the catheter, however, the catheter broke.The procedure was completed successfully with a different device and no patient complications.
 
Manufacturer Narrative
H3 - device evaluated by manufacturer: the renegade hi-flo microcatheter was returned to boston scientific for analysis.The device was partially in the shipping tube when returned.The device showed damage in the form of stretching and a fracture located 1.5cm from the hub.It was also stretched and kinked 9cm from the hub.The device was not completely separated, the inner liner was still attached.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The device was confirmed for shaft stretching and fractures.H6 evaluation code: corrected from cause traced to design to unintended use error caused or contributed to event.
 
Event Description
It was reported that a catheter break occurred.During unpacking of a renegade hi-flo kit, the catheter could not be removed from the packaging loop.The catheter and packaging loop were rinsed with water in an effort to remove the catheter, however, the catheter broke.The procedure was completed successfully with a different device and no patient complications.
 
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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 Key12243433
MDR Text Key264064082
Report Number2134265-2021-09554
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,foreig
Type of Report Initial,Followup,Followup
Report Date 10/11/2021
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 Date01/27/2022
Device Model Number29460
Device Catalogue Number29460
Device Lot Number0025273892
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2021
Initial Date Manufacturer Received 07/22/2021
Initial Date FDA Received07/28/2021
Supplement Dates Manufacturer Received08/25/2021
09/20/2021
Supplement Dates FDA Received09/17/2021
10/11/2021
Patient Sequence Number1
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