MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035421030
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject main coil was unable to detach using the power supply.The procedure was completed successfully without any clinical consequences to the patient.The subject coil was returned for analysis and the device investigation revealed that the subject main coil was prematurely detached/separated during use.
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.During visual and microscopic inspection, it was observed that the main coil was returned detached and packed separately.The coil delivery wire was seen to be kinked/bent in multiple areas and the main coil was seen to be detached /separated from the delivery wire.The main coil was seen to be kinked/bent.Functional inspection could not be performed as the main coil was returned already detached.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 not confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.During analysis, coil delivery wire and main coil was noted to be kinked/bent.The procedure could not be performed as the main coil was observed to be detached/separated from the delivery wire, with the coil already returned in a detached state, hence an assignable cause of not confirmed will be assigned to as reported code main coil failed/unable to detach.The main coil was seen to be detached therefore an assignable cause of procedural factors will be assigned to as analyzed codes main coil prematurely detached/separated during and main coil kinked/bent as it 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.The delivery wire was seen to be kinked bent; this can be presumed to have been caused by handling of the device.The as analyzed code coil delivery wire kinked bent will be assigned handling damage as this complaint appears to be associated with handling of the product or portion of the product during the procedure.

• Brand Name: TARGET 360 NANO 1MM X 3CM
• 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: 21196740
• Report Number: 3008881809-2025-00046
• Device Sequence Number: 8534500
• Product Code: HCG
• UDI-Device Identifier: 04546540697974
• UDI-Public: (01)04546540697974(17)260121(10)24127338
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2025

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 Expiration Date: 01/21/2026
• Device Catalogue Number: M0035421030
• Device Lot Number: 24127338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• 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