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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TREVO TRAK 21 MICROCATHETER 162CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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TREVO TRAK 21 MICROCATHETER 162CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number 90338
Device Problem Component Missing (2306)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/14/2020
Event Type  malfunction  
Manufacturer Narrative
The device is not available to the manufacturer.
 
Event Description
It was reported that during the procedure for m1 occlusion, subject microcatheter was used to facilitate retriever to target occlusion.Physician had successful first pass using subject microcatheter and retriever.Upon second pass, physician noted that distal r/o marker for the subject catheter was not visible.The distal marker was no present upon physician inspection and was confirmed under fluoroscopy that the marker was not within patient body.The physician continued the procedure and patient had full revascularization as the procedure was completed successfully.
 
Event Description
It was reported that during the procedure for m1 occlusion, subject microcatheter was used to facilitate retriever to target occlusion.Physician had successful first pass using subject microcatheter and retriever.Upon second pass, physician noted that distal r/o marker for the subject catheter was not visible.The distal marker was no present upon physician inspection and was confirmed under fluoroscopy that the marker was not within patient body.The physician continued the procedure and patient had full revascularization as the procedure was completed successfully.
 
Manufacturer Narrative
Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.As per the available information the patients tortuosity was above average.The device was not returned.It is probable that the device was damaged during the clinical procedure causing the reported event.An assignable cause of procedural factors will be assigned to this complaint as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
 
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Brand Name
TREVO TRAK 21 MICROCATHETER 162CM
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
MDR Report Key10519051
MDR Text Key206988286
Report Number3012931345-2020-00137
Device Sequence Number1
Product Code DQO
UDI-Device Identifier07613327313956
UDI-Public07613327313956
Combination Product (y/n)N
PMA/PMN Number
K192122
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/07/2021
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 Date05/10/2022
Device Model Number90338
Device Catalogue Number90338
Device Lot Number0000045119
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/14/2020
Initial Date FDA Received09/10/2020
Supplement Dates Manufacturer Received12/29/2020
Supplement Dates FDA Received01/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
FLOWGATE 2 BALLOON CATHETER (STRYKER); TREVO NXT RETRIEVER (STRYKER)
Patient Age73 YR
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