MAUDE Adverse Event Report: Stryker Neurovascular Cork TARGET TETRA 1.5MM X 3.0CM; Device, Neurovascular Embolization

Catalog Number	TG5411530
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when physician attempted to insert the subject coil into the microcatheter, the resistance was encountered at the hub.The physician withdrew the delivery wire and introducer sheath for inspection; a thrombus was observed within the introducer sheath.The subject device was replaced, and the procedure was completed successfully.

• Brand Name: TARGET TETRA 1.5MM X 3.0CM
• Common Device Name: Device, Neurovascular Embolization
• Manufacturer (Section D): Stryker Neurovascular Cork; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): Stryker Neurovascular Cork; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; +1(510)413-2500
• MDR Report Key: 50867854
• Report Number: 3008881809-2026-00589
• Device Sequence Number: 10690530
• Product Code: HCG
• UDI-Device Identifier: 07613327580105
• UDI-Public: (01)07613327580105(17)280405(10)25554109
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K242243
• 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): 09/23/2026

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 Catalogue Number: TG5411530
• Device Lot Number: 25554109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2025
• 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: Excelsior SL-10 Microcatheter (Stryker).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown