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

Model Number	90338
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
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 subject microcatheter was returned with the retriever used in the procedure.There was no packaging returned with the devices, therefore it cannot be confirmed that the correct device was returned.During visual inspection, there was blood noted within the hub/rhv.There was some dried blood proximal end of catheter shaft.There were no other visual anomalies noted to the device.During functional testing, the catheter was flushed, and blood exited.An attempt was made top advance the retriever into the hub, but it was not possible due to blood at the proximal end of the catheter.A patency mandrel was unable to be advanced beyond the proximal end of the catheter.The catheter was cut to identify the occlusion at the proximal end and some of the ptfe inner lining was noted to have been peeled off at the end of the catheter shaft.The device failed to meet specification when received for complaint investigation based on the analyzed anomalies noted to the device.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 device was prepared for use as per the directions for use, the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.It is probable that the inner ptfe lining peeled due to the difficulty experienced in advancing the retriever to the catheter hub.An assignable cause of procedural factors will be assigned to the reported event and to the analyzed events, 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.
Event or Problem Description
It was reported that the during the procedure, the subject catheter was used to approach the lesion site.A retriever was then attempted to approach afterward but was stuck at the hub of the subject catheter.Physician then proceeded to remove the stuck retriever and replaced it with a similar product.The procedure was completed successfully and no clinical consequences was noted to the patient.Analysis of the returned subject catheter revealed that the ptfe inner lining peeling at the proximal end of the subject catheter shaft was peeling.Therefore, based on this information the event is deemed reportable with an awareness date of (b)(6) 2021.No clinical consequences were reported to the patient due to this event.

• Brand Name: TREVO TRAK 21 MICROCATHETER 162CM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11376313
• Report Number: 3012931345-2021-00037
• Device Sequence Number: 3847342
• Product Code: DQO
• UDI-Device Identifier: 07613327313956
• UDI-Public: 07613327313956
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 02/24/2021

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: 05/26/2022
• Device Model Number: 90338
• Device Catalogue Number: 90338
• Device Lot Number: 45888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2020
• 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