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	10/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The catheter (subject device) was returned for analysis and it was discovered that the catheter (subject device) shaft has a hole/perforation.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.During visual test, the catheter shaft was seen to have a hole/perforation 14cm from the catheter hub, the catheter distal shaft was seen to be flat/crushed 15cm from the distal end, and the catheter tip and hub were intact.During a functional test, the catheter was flushed, and a leak was noted 14 cm from the catheter hub.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.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.Additional information provided by the customer indicated that no damage was noted to the packaging prior to opening the packaging, flush was given when the product was taken out from the dispenser hoop, there was no friction or resistance while removing the catheter from the dispenser hoop, the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, and continuous flush was set up and maintained throughout the clinical procedure.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 to the as reported and as analyzed code 'catheter shaft leak during preparation' and to the as analyzed 'catheter shaft has hole/perforation' and 'catheter shaft flat/crushed' codes 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.

• 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: 16030165
• Report Number: 3012931345-2022-00231
• Device Sequence Number: 7224636
• 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): 12/21/2022

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: 11/19/2023
• Device Model Number: 90338
• Device Catalogue Number: 90338
• Device Lot Number: 0000092011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2021
• 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