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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE STC 18; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION RENEGADE STC 18; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number 80617
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 08/13/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the device came out in two pieces.A renegade stc-18 was selected for use.Upon preparation, the device came out in two pieces when taken out of the hoop and never entered the patient's body.The device was severed about 10 inches below the wire and flushed port.The procedure was completed with another of the same device.No complications reported and patient is fine.
 
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Brand Name
RENEGADE STC 18
Common Device Name
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8966480
Report Number2134265-2019-10723
Device Sequence Number2041760
Product Code DQO
UDI-Device Identifier08714729444473
UDI-Public08714729444473
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K023681
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/05/2019
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
Operator of Device Health Professional
Device Expiration Date03/24/2022
Device Model Number80617
Device Catalogue Number80617
Device Lot Number0023685255
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/16/2019
Initial Report FDA Received Date09/05/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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