MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035475150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the proximal portion of the pusher got broken/fractured and remained inside the release mechanism.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated.Due to the automated mes (manufacturing execution system) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the subject coil delivery wire was seen to be kinked/bent.The coil delivery wire proximal end was seen to be broken/fractured.The main coil and introducer sheath were intact.The functional inspection was not carried out due to the damage 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.The reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that the proximal portion of the subject coil delivery wire was broken/fractured inside the power supply device and the coil could not be detached.The device was confirmed to be in good condition prior to use.One coil had been successfully detached using the power supply prior to the reported event.The procedure was successfully completed with new devices.The product was returned and the delivery wire was noted to be broken close to the proximal contact and the proximal contact was located inside the returned power supply.It is likely that the delivery wire was broken during insertion into the power supply and this resulted in the detachment failure.Because this complaint appears to be associated with handling of the product or portion of the product during the procedure, a probable cause of handling damage will be assigned to the as reported ¿main coil failed/unable to detach¿, ¿coil delivery wire broken/fractured during use¿ and as analyzed ¿coil delivery wire broken/fractured during use, ¿coli delivery wire kinked/bent¿ codes.
Event or Problem Description
It was reported that during procedure, the proximal portion of the pusher got broken/fractured and remained inside the release mechanism.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 360 SOFT 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 ; 5104132500
• MDR Report Key: 23824910
• Report Number: 3008881809-2025-00719
• Device Sequence Number: 15711065
• Product Code: HCG
• UDI-Device Identifier: 04546540676504
• UDI-Public: (01)04546540676504(17)300614(10)25672149
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 02/03/2026

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: M0035475150
• Device Lot Number: 25672149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2025
• 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 (STRYKER).; SL-10 MICROCATHETER (STRYKER).
• Patient Sex: Male