MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 STANDARD 15 MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035461540
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject main coil failed to detach.The physician tired more than 8 times with two different power supplies.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.The subject device was returned for analysis and the device investigation revealed that the subject coil was prematurely detached/separated during use.No clinical consequences were reported to the patient due to this event.
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.During visual inspection, the subject coil delivery wire and introducer sheath were not returned.The subject main coil was seen to be detached with no anomalies.For functional inspection, main coil failed/unable to detach functional test ¿ unable to perform as main coil returned detached.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 " 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 surgical procedure, the physician made more than eight attempts using two different power supply detachment systems to detach the subject coil but was still unable to achieve detachment within the aneurysm sac.In order to successfully complete the procedure, the subject coil was retrieved and replaced with a new subject coil.Additional information from the customer indicated that the patient¿s anatomy was moderately tortuous, and the proximal end of the delivery wire had not been wiped with alcohol prior to insertion into the power supply system.The device was returned for analysis.The subject main coil was noted to be prematurely detached/separated from the delivery wire.Since the subject coil delivery wire and introducer sheath were not returned, no functional testing could be performed.An assignable cause of procedural factors will be assigned to the reported code " main coil failed/unable to detach " as it could not be replicated during analysis however, the analysis results are consistent with the reported event.It is probable that the proximal end of the delivery wire was not wiped with alcohol prior to inserting into the power supply, resulting in reported defects in the device.An assignable cause of procedural factors will be assigned to ¿main coil prematurely detached/separated during use.' although there is no conclusive evidence identifying the exact cause of the event, it likely occurred during retrieval of the subject coil through moderately tortuous anatomy.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.

• Brand Name: TARGET 360 STANDARD 15 MM X 40CM
• 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: 24730483
• Report Number: 3008881809-2026-00178
• Device Sequence Number: 21149751
• Product Code: HCG
• UDI-Device Identifier: 07613252192534
• UDI-Public: (01)07613252192534(17)271002(10)25184583
• 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
• Report Date (Section B): 03/30/2026

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: M0035461540
• Device Lot Number: 25184583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2024
• 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: INZONE POWER SUPPLY (STRYKER).
• Patient Sex: Unknown