MAUDE Adverse Event Report: Stryker Neurovascular Cork TARGET TETRA 2.0MM X 2.5CM; Device, Neurovascular Embolization

Catalog Number	TG5412025
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during coil embolization using a compatible-lumen microcatheter, the resistance was encountered while attempting to retrieve the subject coil.Upon withdrawal, the subject coil stretched and prematurely detached inside the microcatheter shaft.Consequently, the subject coil and microcatheter were retrieved together.The procedure was completed successfully using a replacement coil and microcatheter.
Event or Problem Description
It was reported that during coil embolization using a compatible-lumen microcatheter, the resistance was encountered while attempting to retrieve the subject coil.Upon withdrawal, the subject coil stretched and prematurely detached inside the microcatheter shaft.Consequently, the subject coil and microcatheter were retrieved together.The procedure was completed successfully using a replacement coil and microcatheter.
Additional Manufacturer Narrative
Due to automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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.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.It was reported that during coil embolization using a compatible lumen microcatheter (unknown type), resistance was encountered while attempting to retrieve the subject coil.The coil was withdrawn; however, coil stretching or premature detachment was subsequently observed.As a result, the coil and microcatheter were retrieved together.The procedure was continued using a different coil and microcatheter and was completed successfully.Additional information provided by the customer indicated that no anomalies were noted to the device prior to use on the patient, the device was prepared for use as per the directions for use, continuous flush was set up and maintained throughout the clinical procedure, the tapered distal end of the introducer sheath was securely seated in the microcatheter hub, the rhv was appropriately tightened without over- or under-tightening and was opened sufficiently to allow the device to pass through without damage, torque was not applied to the delivery wire during coil manipulation, and the coil was advanced slowly and carefully without excessive force.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, a cause of undeterminable will be assigned to as reported 'coil difficult to remove/withdraw from catheter', 'main coil stretched', 'coil in catheter friction' and 'main coil prematurely detached/separated during use'.

• Brand Name: TARGET TETRA 2.0MM X 2.5CM
• 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: 50465998
• Report Number: 3008881809-2026-00539
• Device Sequence Number: 9811390
• Product Code: HCG
• UDI-Device Identifier: 07613327578577
• UDI-Public: (01)07613327578577(17)301005(10)25886685
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 10/02/2026

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 Catalogue Number: TG5412025
• Device Lot Number: 25886685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/12/2026
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 08/27/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2025
• 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: Microcatheter (Unknown Manufacturer)
• Patient Sex: Unknown