MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 2MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035452060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes system, there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the subject main coil was seen to be detached, and the subject main coil was seen to be stretched and kinked.Functional inspection could not be carried out due to damage.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 "coil introducer sheath friction" it could not be replicated during device analysis; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that during the surgery coil got stuck during advancing, no as such other additional information provided by customer.The device was returned for analysis, and the main coil was found to be kinked/bent and stretched.The main coil was noted to be detached/separated from the delivery wire.Coil in catheter friction could not be confirmed; however, the analysis results are consistent with the reported event based on the all-available information and analysis of the device there is no conclusive evident but it is probable that the subject coil pushed/pulled against resistance may cause the reported and analyzed defect therefore an assignable cause of 'procedural factors' will be assigned to as reported "coil introducer sheath friction" and as analyzed "main coil prematurely detached/separated during use", "main coil kinked/bent" and "main coil stretched" 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.
Event or Problem Description
The subject coil was returned for analysis, and it was discovered that the subject main coil was noted to be detached/separated from the delivery wire.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET HELICAL NANO 2MM X 6CM
• 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: 24901771
• Report Number: 3008881809-2026-00229
• Device Sequence Number: 13193518
• Product Code: HCG
• UDI-Device Identifier: 07613252600381
• UDI-Public: (01)07613252600381(17)301025(10)25910548
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• 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): 04/16/2026

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: M0035452060
• Device Lot Number: 25910548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2025
• 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
• Patient Sex: Unknown