MAUDE Adverse Event Report: Stryker Neurovascular Cork TARGET 360 SOFT 6MM X 30CM; Device, Neurovascular Embolization

Catalog Number	M0035476300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject coil could not be advanced through the microcatheter.The subject coil was returned for analysis and it was discovered that the subject 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.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil delivery wire was broken/fractured, the main coil was not returned.The coil delivery wire was kinked/bent.A functional inspection, was unable to perform as the coil was not returned.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.The reported event is covered in the device directions for use (dfu).Also, 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.Based on a review of all available information and the analysis of the returned device it is probable that the damage noted to the returned coil was caused by the friction that was noted in the shaft of the microcatheter.The as reported 'coil in catheter friction' will be assigned procedural factors 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 as analyzed 'coil delivery wire broken/fractured during use' and 'coil delivery wire kinked bent' will be assigned handling damage as it appears to be associated with handling of the product or portion of the product during the procedure.

• Brand Name: TARGET 360 SOFT 6MM X 30CM
• 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 ; +1(510)413-2500
• MDR Report Key: 50782607
• Report Number: 3008881809-2026-00574
• Device Sequence Number: 10529545
• Product Code: HCG
• UDI-Device Identifier: 04546540676559
• UDI-Public: (01)04546540676559(17)301014(10)25884177
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 09/15/2026

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: M0035476300
• Device Lot Number: 25884177
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/29/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2025
• 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: Excelsior SL-10 (Stryker)
• Patient Age: 60 YR
• Patient Sex: Male