MAUDE Adverse Event Report: Stryker Neurovascular Cork TARGET 360 ULTRA 5MM X 15CM; Device, Neurovascular Embolization

Catalog Number	M0035425150
Medical Device Problem Codes	Fracture (1260); Expulsion (2933); Premature Separation (4045)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during coronary artery fistula procedure, planned for coil embolization.After delivering the guiding catheter to the target position via the radial artery, the physician delivered the microcatheter to the fistula opening.A stryker coil was delivered, positioned, and successfully detached.The physician then delivered an additional coil.After flushing, delivery was initiated with no resistance.After inserting, the physician was dissatisfied with the result and attempted to reposition the coil 3 times, still unsatisfactory.The physician then attempted to retrieve the subject coil but found it had already detached and could not be retrieved.Angiography confirmed the subject coil had not migrated.The physician then withdrew the delivery wire, and after taken out it was found a metal wire connected at tip of the delivery wire.The physician then used coils and a microcatheter of another brand to continue inserting until satisfied, then concluded the procedure.After the patient went back to ward, the nurse discovered a metal wire at the radial artery occlusion area (external the skin).Following angiography revealed a wire-like structure extending from coronary artery to the radial artery.The physician assessed that the wire-like structure would not cause harm to the patient, so the external portion was cut off.The procedure was completed successfully.No additional information is available.
Event or Problem Description
It was reported that during coronary artery fistula procedure, planned for coil embolization.After delivering the guiding catheter to the target position via the radial artery, the physician delivered the microcatheter to the fistula opening.A stryker coil was delivered, positioned, and successfully detached.The physician then delivered an additional coil.After flushing, delivery was initiated with no resistance.After inserting, the physician was dissatisfied with the result and attempted to reposition the coil 3 times, still unsatisfactory.The physician then attempted to retrieve the subject coil but found it had already detached and could not be retrieved.Angiography confirmed the subject coil had not migrated.The physician then withdrew the delivery wire, and after taken out it was found a metal wire connected at tip of the delivery wire.The physician then used coils and a microcatheter of another brand to continue inserting until satisfied, then concluded the procedure.After the patient went back to ward, the nurse discovered a metal wire at the radial artery occlusion area (external the skin).Following angiography revealed a wire-like structure extending from coronary artery to the radial artery.The physician assessed that the wire-like structure would not cause harm to the patient, so the external portion was cut off.The procedure was completed successfully.No additional information is available.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are 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.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, a cause of undeterminable was assigned to the as reported 'main coil prematurely detached/separated during use', 'coil delivery wire broken/fractured during use', 'main coil protrusion', 'unretrieved device fragments.'.

• Brand Name: TARGET 360 ULTRA 5MM X 15CM
• 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: 25669776
• Report Number: 3008881809-2026-00411
• Device Sequence Number: 21434262
• Product Code: HCG
• UDI-Device Identifier: 04546540675965
• UDI-Public: (01)04546540675965(17)310105(10)26057736
• 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): 09/15/2026

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: M0035425150
• Device Lot Number: 26057736
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2026
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 06/30/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2026
• 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: 6F GUIDING CATHETER (STRYKER); COILS (STRYKER); SL 10 CATHETER (STRYKER)
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Race: Asian