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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 2 of 3 report.The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the thrombus recovery procedure for mca lesions, the physician used an access catheter and subject microcatheter to successfully deliver a stent retriever.However, the blood clots remained, the physician used a reperfusion catheter in combination with a microcatheter to access the treating site but could not cross the region.Therefore, both devices were withdrawn.The physician then reattempted to approach the aneurysm by combining the subject catheter with another catheter but was unsuccessful.The physician gave up treatment and it was reported that the procedure was not completed successfully.The subject catheter fragments were noted in the peripheral area in the postoperative ct imaging.The location of catheter fragments are unknown for the specific position.No further information is available.
Additional Manufacturer Narrative
¿ h4 manufacturing date ¿ added.¿ d4 expiration date - added.There are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional inspection were not performed because the subject device 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.Additional information provided by the customer indicated that the device confirmed to be in good condition during preparation/prior to use on the patient, device was prepared as per the dfu, and continuous flush set up and maintained throughout the clinical procedure.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that during the thrombus recovery procedure for mca lesions, the physician used an access catheter and subject microcatheter to successfully deliver a stent retriever.However, the blood clots remained, the physician used a reperfusion catheter in combination with a microcatheter to access the treating site but could not cross the region.Therefore, both devices were withdrawn.The physician then reattempted to approach the aneurysm by combining the subject catheter with another catheter but was unsuccessful.The physician gave up treatment and it was reported that the procedure was not completed successfully.The subject catheter fragments were noted in the peripheral area in the postoperative ct imaging.The location of catheter fragments are unknown for the specific position.No further information is available.

• 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: 12332370
• Report Number: 3012931345-2021-00134
• Device Sequence Number: 4454507
• 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): 12/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/10/2022
• Device Model Number: 90338
• Device Catalogue Number: 90338
• Device Lot Number: 46848
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 12/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2020
• 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: AXS CATALYST 6 MICROCATHETER (STRYKER).; PENUMBRA 3 MAX CATHETER (PENUMBRA).; PENUMBRA 4 MAX CATHETER (PENUMBRA).; TREVO NXT PROVUE RETRIEVER (STRYKER).; TREVO TRAK 14 MICROCATHETER (STRYKER).; AXS CATALYST 6 MICROCATHETER (STRYKER); PENUMBRA 3 MAX CATHETER (PENUMBRA); PENUMBRA 4 MAX CATHETER (PENUMBRA); TREVO NXT PROVUE RETRIEVER (STRYKER); TREVO TRAK 14 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown