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	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned, and the lot number was confirmed with the packaging returned with the device.During visual inspection, the catheter shaft was found to be kinked/bent at 8.5cm from the catheter hub and flat/crushed at 6.5cm from the catheter tip.When the catheter was flushed, a leak was noted 10.5cm from the catheter hub where a hole was found on the shaft.During functional inspection, the catheter was difficult to flush; a leak was noted at 10.5cm from the catheter hub.A hole in the catheter shaft was noted.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 was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that no damage was noted to the packaging prior to preparation of the device, no other anomalies were noted to the device after removal from the packaging or prior to preparation, the device was prepared as per the dfu, the dispenser hoop was flushed before removing the catheter, and no resistance was encountered when removing the catheter from the dispenser hoop.The hole found on the catheter shaft would not have left the manufacturing process due to the controls in place.An assignable cause of handling damage will be assigned the analyzed events of catheter shaft kinked/bent, catheter shaft flat/crushed, catheter shaft leak during preparation and catheter shaft has hole/perforation in this complaint since this complaint appears to be associated with handling of the product or portion of the product upon removal of the product from the packaging/preparation of the product prior to use.
Event or Problem Description
Analysis of the device revealed that the microcatheter (subject device) had a hole in the shaft; therefore, based on this information the event is deemed reportable and mdr will be filed with an awareness date of 14-feb-2023.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• 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: 16588075
• Report Number: 3012931345-2023-00051
• Device Sequence Number: 6099759
• 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: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/21/2023

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: 08/03/2024
• Device Model Number: 90338
• Device Catalogue Number: 90338
• Device Lot Number: 0000166209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2022
• 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