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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE HI-FLO; CATHETER, CONTINUOUS FLUSH
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BOSTON SCIENTIFIC CORPORATION RENEGADE HI-FLO; CATHETER, CONTINUOUS FLUSH Back to Search Results
Model Number 29420
Device Problems Contamination (1120); Unsealed Device Packaging (1444)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/22/2022
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that a device contamination occurred.A 135/20 renegade hi-flo catheter was selected for use.During preparation, it was noted that the packaging was not sealed and the sterility of the device was compromised.The procedure was completed with another of same device.No complications were reported and patient was stable post procedure.
 
Event Description
It was reported that a device contamination occurred.A 135/20 renegade hi-flo catheter was selected for use.During preparation, it was noted that the packaging was not sealed and the sterility of the device was compromised.The procedure was completed with another of same device.No complications were reported and patient was stable post procedure.
 
Manufacturer Narrative
A2 - age at time of event: 18 years or older.Device evaluated by mfr: the device with its packaging has been received for analysis.The outer box seal was broken, and the inner pouch had been opened (across the top of the pouch and down halfway of the right side).Along the top of the pouch were residue signs that it had been sealed and pulled open.The device itself was in the shipping hoop and showed no signs of use.The residual of the sealing process on the pouch confirms the pouch had been sealed at one time.
 
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Brand Name
RENEGADE HI-FLO
Type of Device
CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORK LIMITED
model farm road
cork
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key14408855
MDR Text Key291735580
Report Number2134265-2022-05185
Device Sequence Number1
Product Code KRA
UDI-Device Identifier08714729280644
UDI-Public08714729280644
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K140329
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number29420
Device Catalogue Number29420
Device Lot Number0027457034
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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