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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RENEGADE STC 18; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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RENEGADE STC 18; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number 80617
Device Problems Break (1069); Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/13/2020
Event Type  malfunction  
Event Description
It was reported that the tip of the microcatheter was fractured.A renegade stc 18 catheter infusion was selected for use in transarterial chemoembolization (tace).During preparation, the outer package was unpacked.However, it was discovered that the tip of the microcatheter was fractured.The procedure was completed with a different device.There were no complications reported and the patient is stable.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device was returned in the original shipping tube.The device was taken out of the shipping hoop and a portion of the device was completely detached from the rest of the shaft.The portion that was detached was approximately 8cm long from the hub.The shipping hoop was hydrated, and the remainder of the devices shaft was removed with no issues.No other damage was noticed.Inspection of the remainder of the device apart from the observed damage, revealed no other damage or irregularities.The complaint for a shaft break was confirmed.
 
Event Description
It was reported that the tip of the microcatheter was fractured.A renegade stc 18 catheter infusion was selected for use in transarterial chemoembolization (tace).During preparation, the outer package was unpacked.However, it was discovered that the tip of the microcatheter was fractured.The procedure was completed with a different device.There were no complications reported and the patient is stable.
 
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Brand Name
RENEGADE STC 18
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
MDR Report Key10848156
MDR Text Key216942275
Report Number2134265-2020-15831
Device Sequence Number1
Product Code DQO
UDI-Device Identifier08714729444442
UDI-Public08714729444442
Combination Product (y/n)N
PMA/PMN Number
K023681
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/27/2021
Device Model Number80617
Device Catalogue Number80617
Device Lot Number0022569573
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2021
Date Manufacturer Received01/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/27/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age63 YR
Patient Weight76
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