MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035424080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 inspection of the device revealed that the subject device coil delivery wire was kinked.The main coil was stretched, the suture damaged and fractured.Functional test was passed as the main coil detached using a demo inzone detachment on first attempt.The reported complaint could not be confirmed; however, the analysis results are consistent with the reported event.The subject device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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, during an mca (right middle cerebral artery) aneurysm embolization procedure, the physician successfully super selected the microcatheter into the aneurysm under the guidance of a subject device.Subsequently, a subject device was delivered into the aneurysm through the microcatheter.However, during the detachment process, the subject coil could not be detached smoothly.After adjustments, an attempt was made to detach it again, but it still could not be detached.During analysis, the coil delivery wire was kinked near the proximal contact, the main coil was severely damaged.The suture was broken; the subject main coil was fractured and extremely stretched.An assignable cause of 'procedural factors' will be assigned to the reported main coil failed/unable to detach these defects appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.An assignable cause of 'handling damage' will be assigned to the assignable cause coil delivery wire kinked/bent as the defect appears to be associated with handling of the product or portion of the product during preparation.An assignable cause of procedural factors will be assigned to the assignable cause main coil stretched, main oil suture damaged and main oil broken/fractured during use these defects appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.
Event or Problem Description
Analysis of the returned device found that the subject device was broken/fractured during use.There was no clinical consequence to the patient due to this event.

• Brand Name: TARGET 360 ULTRA 4MM X 8CM
• 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: 23836085
• Report Number: 3008881809-2025-00733
• Device Sequence Number: 5094086
• Product Code: HCG
• UDI-Device Identifier: 04546540675927
• UDI-Public: (01)04546540675927(17)290903(10)25096884
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/18/2025

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: M0035424080
• Device Lot Number: 25096884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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: SL-10 MICROCATHETER (STRYKER).
• Patient Sex: Unknown