MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035421020
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject coil delivery wire was seen to be kinked/bent, main coil was seen to be detached.The main coil and coil introducer sheath were not returned.Functional inspection was unable to perform as main coil was not returned.The reported event is covered in the device direction 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 main coil failed/unable to detach was not confirmed during analysis due it could not be replicated during device analysis as the main coil was not retuned.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.An assignable cause of not confirmed will be assigned to the event main coil failed/unable to detach.As defects were not confirmed during functional testing as coil was not returned.Based on the all-available information and analysis of the device it is probable that the subject coil pushed/pulled against resistance may cause the analyzed defect therefore an assignable cause of 'procedural factors' will be assigned to analyzed main coil prematurely detached/separated during use as this complaint 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 as analyzed coil delivery wire kinked/bent since this issue is most likely due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.
Event or Problem Description
It was reported that the subject coil could not be removed/detached despite the acoustic signal from the power supply.The subject coil was returned for analysis and the device investigation revealed that the subject main coil failed unable to detach was not confirmed and subject coil was found prematurely detached during use.The procedure was completed successfully without any clinical consequences to the patient.

• Brand Name: TARGET 360 NANO 1MM X 2CM
• 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: 24218817
• Report Number: 3008881809-2026-00056
• Device Sequence Number: 18483137
• Product Code: HCG
• UDI-Device Identifier: 04546540697967
• UDI-Public: (01)04546540697967(17)300603(10)25651030
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113412
• 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): 01/29/2026

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: M0035421020
• Device Lot Number: 25651030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• 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: INZONE DETACHMENT SYSTEM (STRYKER)
• Patient Sex: Unknown