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

Catalog Number	M0035421030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
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 delivery wire was fractured 132.5cm from the proximal end.The main coil was seen to be kinked.Functional inspection could not be carried out due to the delivery wire being fractured.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 the damage noted to the delivery wire during 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 under fluoroscopy, the coil could not be detached after three consecutive attempts.The coil was removed and replaced with another coil of the same model to complete the procedure.The device was returned for analysis, and it was noted that the delivery wire was broken/fractured which is likely to have caused the detachment failure.The coil was damaged and still attached to the delivery wire.Based on a review of all available information and the analysis of the returned device it is probable that the delivery was damaged during use.An assignable cause of procedural factors will be assigned to the reported event: ¿main coil failed/unable to detach¿ and to the analyzed events: ¿coil delivery wire broken/fractured during use¿ and ¿main coil kinked/bent¿.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 device was returned for analysis and the device investigation revealed that the coil delivery wire was broken/fractured during use.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 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: 23376726
• Report Number: 3008881809-2025-00583
• Device Sequence Number: 18383689
• Product Code: HCG
• UDI-Device Identifier: 04546540697974
• UDI-Public: (01)04546540697974(17)300106(10)25387386
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2025

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 Catalogue Number: M0035421030
• Device Lot Number: 25387386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2025
• 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: GUIDEWIRE (UNKNOWN).; INZONE POWER SUPPLY (STRYKER).; SL-10 MICROCATHETER (STRYKER).; TARGET COILS (STRYKER).
• Patient Sex: Unknown
• Patient Race: Asian