MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035433060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the operator encountered resistance when pushing the subject coil into the microcatheter.When the operator was pulling the subject coil back, it detached from the wire and became stuck in the stroke of the catheter.A 10-minute surgical delay was reported due to this event.The procedure was completed successfully.No clinical consequences were reported due to this event.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated.D9.Product available to stryker ¿ updated.D9.Returned to manufacturer on ¿updated.Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the main coil was returned detached, stretched, suture damaged and kinked.A functional inspection was unable to perform 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 'main coil prematurely detached/separated during use' was confirmed during analysis.The reported 'main coil difficulty inserting' could not be replicated; 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.Additional information provided by the customer indicated that resistance was felt when pushing the coil into the microcatheter, the coil detached from the wire when pulling back and became stuck in the stroke of the sl-10, the device was prepared as per the dfu, and there was no damage noted to the packaging.During analysis, the main coil was noted to be detached, stretched, kinked and the suture was damaged.There were no other anomalies noted to the device.It is probable that due to the damage of the coil, the device did not work as intended.An assignable cause of procedural factors will be assigned to the as reported 'main coil prematurely detached/separated during use' and 'main coil difficulty inserting' as well as the as analyzed 'main coil prematurely detached/separated during use', 'main coil stretched', 'main coil kinked/bent' and 'main coil suture damage' since these defects appear 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
It was reported that during the procedure, the operator encountered resistance when pushing the subject coil into the microcatheter.When the operator was pulling the subject coil back, it detached from the wire and became stuck in the stroke of the catheter.A 10-minute surgical delay was reported due to this event.The procedure was completed successfully.No clinical consequences were reported due to this event.

• Brand Name: TARGET HELICAL ULTRA 3MM 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: 23625022
• Report Number: 3008881809-2025-00662
• Device Sequence Number: 8977205
• Product Code: HCG
• UDI-Device Identifier: 04546540676078
• UDI-Public: (01)04546540676078(17)300726(10)25752897
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/09/2026

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: M0035433060
• Device Lot Number: 25752897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 11/22/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2025
• 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: EXCELSIOR SL-10 CATHETER (STRYKER).
• Patient Age: 53 YR
• Patient Sex: Female