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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 M001183020
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/08/2018
Event Type  malfunction  
Event Description
A patient underwent cardiac catheterization for urgent balloon dilation of severe aortic coarctation.During the procedure, a small distal fragment of the high flow renegade microcatheter tip broke off and was retained in the patient.
 
Event Description
A patient underwent cardiac catheterization for urgent balloon dilation of severe aortic coarctation.During the procedure, a small distal fragment of the high flow renegade microcatheter tip broke off and was retained in the patient.Patient outcome: pt is stable.Device tip was left in place: no retrieval.Unknown if the patient required additional medical care or treatment as a result of the device failure.
 
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Brand Name
RENEGADE¿ HI-FLO¿ KIT
Type of Device
CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key7769856
MDR Text Key116658640
Report Number7769856
Device Sequence Number1
Product Code KRA
UDI-Device Identifier08714729280774
UDI-Public(01)08714729280774(17)190228(10)20364964
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 07/16/2018,07/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2018
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM001183020
Device Catalogue NumberM001183020
Device Lot Number20364964
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/16/2018
Event Location Hospital
Date Report to Manufacturer08/09/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age90 DA
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