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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION RENEGADE; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number 29417
Device Problems Difficult to Insert (1316); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2021
Event Type  malfunction  
Event Description
It was reported that the coating peeled off.The target lesion was located in the liver area.A renegade was selected for use.During procedure, after the first session chemo drug injection in a lesion another artery selection was performed.However, the device could not be pushed as the position of the renegade is just in the tip of the rh catheter when observed under angiogram but it can't be push over.Both catheter and guidewire were then removed directly from the patient's body without any friction noted.Upon inspection, the catheter was astringent to touch as the surface was not smooth, thus it was presumed that the hydrophilic coating of renegade catheter might be peeled off during the operation.The procedure was completed with a different device.No complications reported and patient is stable.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device was inspected for any damage or irregularities.The renegade showed damage in the hydrophilic coating.Under microscope analysis areas are seen where the coating has sheared off or been pushed back on itself at 60 cm and 62.5 cm.A coating bulge was seen at 45.5 cm from the tip.Stretching was also noted at 7.5 cm to 8.5 cm from the tip.Device analysis determined the condition of the returned device was consistent with the reported information.Peeling or shearing of the coating was observed.There was no evidence of any damage or irregularities contributing to the reported insertion difficulty, which could not be confirmed because the clinical circumstances could not be replicated.
 
Event Description
It was reported that the coating peeled off.The target lesion was located in the liver area.A renegade was selected for use.During procedure, after the first session chemo drug injection in a lesion another artery selection was performed.However, the device could not be pushed as the position of the renegade is just in the tip of the rh catheter when observed under angiogram but it can't be push over.Both catheter and guidewire were then removed directly from the patient's body without any friction noted.Upon inspection, the catheter was astringent to touch as the surface was not smooth, thus it was presumed that the hydrophilic coating of renegade catheter might be peeled off during the operation.The procedure was completed with a different device.No complications reported and patient is stable.
 
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Brand Name
RENEGADE
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11561068
MDR Text Key242011160
Report Number2134265-2021-03743
Device Sequence Number1
Product Code KRA
UDI-Device Identifier08714729235125
UDI-Public08714729235125
Combination Product (y/n)N
PMA/PMN Number
K973645
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 04/27/2021
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 Date03/29/2022
Device Model Number29417
Device Catalogue Number29417
Device Lot Number0023710351
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2021
Initial Date Manufacturer Received 03/11/2021
Initial Date FDA Received03/24/2021
Supplement Dates Manufacturer Received04/07/2021
Supplement Dates FDA Received04/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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