MAUDE Adverse Event Report: TREVO TRAK 21 MICROCATHETER 162CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	90338
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem 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 or Problem 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.
Additional 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.

• Brand Name: TREVO TRAK 21 MICROCATHETER 162CM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10519051
• Report Number: 3012931345-2020-00137
• Device Sequence Number: 3055323
• Product Code: DQO
• UDI-Device Identifier: 07613327313956
• UDI-Public: 07613327313956
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K192122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 05/10/2022
• Device Model Number: 90338
• Device Catalogue Number: 90338
• Device Lot Number: 0000045119
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 01/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FLOWGATE 2 BALLOON CATHETER (STRYKER); TREVO NXT RETRIEVER (STRYKER)
• Patient Age: 73 YR