MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 1.5MM X 3.0CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5411530
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during ica-t, pca, and supraclinoid aneurysm procedure, the operator first treated the ica-t aneurysm with a web then coiled the l-pca aneurysm.He deployed two coils and then asked for the subject coil.However, when he tried to detach the subject coil, it wouldn't detach.After the operator heard that the power supply gave the long beep he tried to pull the subject coil out of the microcatheter but it remained undetached.He replaced the power supply and tried again, but the subject coil still would not detach.When the operator tried again the subject coil partially detached with the proximal portion in the distal end of the microcatheter.The operator used a new coil, to push the proximal end of the subject coil into the aneurysm and then finished coiling.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during ica-t, pca, and supraclinoid aneurysm procedure, the operator first treated the ica-t aneurysm with a web then coiled the l-pca aneurysm.He deployed two coils and then asked for the subject coil.However, when he tried to detach the subject coil, it wouldn't detach.After the operator heard that the power supply gave the long beep he tried to pull the subject coil out of the microcatheter but it remained undetached.He replaced the power supply and tried again, but the subject coil still would not detach.When the operator tried again the subject coil partially detached with the proximal portion in the distal end of the microcatheter.The operator used a new coil, to push the proximal end of the subject coil into the aneurysm and then finished coiling.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
B2 outcomes attributed to ae: updated due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional inspections were not conducted due to the 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.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.Additional information provided by the customer indicated that no damage was sustained to the delivery wire during use, no thrombus or any other embolic agents were present on the coil detachment zone, the delivery wire and microcatheter markers were verified to be properly aligned under fluoroscopy, the rotating hemostatic valve (rhv) was sufficiently tightened prior to detachment, the power supply was maintained in a stable position, and 4-5 detachment attempts were made.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 the reported events: ¿main coil prematurely detached/separated during use' and 'main coil failed/unable to detach'.

• 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 ; 5104132500
• MDR Report Key: 23589730
• Report Number: 3008881809-2025-00646
• Device Sequence Number: 10178831
• Product Code: HCG
• UDI-Device Identifier: 07613327580105
• UDI-Public: (01)07613327580105(17)270723(10)25029891
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/19/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: TG5411530
• Device Lot Number: 25029891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2024
• 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: ARISTOTLE STANDARD GUIDEWIRE (NON-STRYKER).; HEADWAY MICROCATHETER (NON-STRYKER).; INZONE POWER SUPPLY (STRYKER).; SOFIA CATHETER (NON-STRYKER).; TARGET COIL (STRYKER).
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown