MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY 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	01/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after successful completion of the procedure when the subject catheter was stored in a tray, something like coating substance was found floating in the saline solution in the tray.It is unclear at what point in time this occurred.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
This is 2 of 4 reports.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.The product was not returned.A swirl/sliver of ptfe (polytetrafluoroethylene) coating was returned wrapped inside medical gauze.Upon inspection, it was determined that the ptfe (polytetrafluoroethylene) coating belonged to the guidewire investigated under same parent complaint.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.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.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, the dispenser hoop was flushed and there was no friction or resistance while removing the catheter from the dispenser hoop, the introducer was used when inserting the guidewire into the catheter, and flush was given inside the catheter when inserting the guidewire.The device was not returned for analysis as it was discarded at the hospital; however, a swirl/sliver of the coating substance described in the event description was returned wrapped inside medical gauze.Upon inspection, it was determined that this substance was ptfe coating likely belonging to the guidewire investigated under the same parent complaint.As this coating was ptfe (polytetrafluoroethylene) and not hydrophilic, the as reported 'hydrophilic coating peeling' was not confirmed.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that after successful completion of the procedure when the subject catheter was stored in a tray, something like coating substance was found floating in the saline solution in the tray.It is unclear at what point in time this occurred.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
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 16270014
• Report Number: 3012931345-2023-00014
• Device Sequence Number: 6033329
• 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,Followup
• Report Date (Section B): 03/24/2023

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: 08/02/2024
• Device Model Number: 90338
• Device Catalogue Number: 90338
• Device Lot Number: 165496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2022
• 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
• Patient Sex: Unknown