MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035421540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
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 inspection, the coil delivery wire was seen to be kinked/bent.The coil delivery wire proximal end was seen to be broken/fractured and missing.The introducer sheath was intact.A functional inspection was not required.As the event was confirmed visually.The reported event of 'coil delivery wire kinked/bent' was confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies 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.It was reported that during surgery when physician advanced the subject coil through microcatheter.They observed the delivery wire was kinked.Additional details provided by customer indicated that the patient¿s anatomy was moderately tortuous the device was returned for analysis, during which the coil delivery wire was found to be kinked/bent, and the proximal end was observed to be broken and missing.Based on all available information and analysis of the device, it is probable that the patient¿s tortuous anatomy may have contributed to reported and analyzed defect therefore an assignable cause of 'procedural factors' will be assigned to the reported event of ¿coil delivery wire kinked/bent¿ and to the analyzed event of 'coil delivery wire kinked/bent' and 'coil delivery wire broken/fractured during use¿ as 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 coil (subject device) was returned for analysis, and it was discovered that the coil delivery wire was kinked/bent and was broken/fractured during use.The subject device was reported to be replaced, and the procedure was reported to be completed successfully.No clinical consequences were reported to the patient.

• Brand Name: TARGET 360 NANO 1.5MM X 4CM
• 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: 25086831
• Report Number: 3008881809-2026-00277
• Device Sequence Number: 16093462
• Product Code: HCG
• UDI-Device Identifier: 04546540697998
• UDI-Public: (01)04546540697998(17)271117(10)25293618
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 05/05/2026

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: M0035421540
• Device Lot Number: 25293618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Sex: Unknown