MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 8MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036180820
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The subject coil was returned for analysis and it was discovered that the subject coil was broken/fractured during use.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 seen to be slightly kinked.The main coil was seen to be fractured.The main coil suture was seen to be damaged.The main coil was extremely stretched.A functional inspection was not required.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 "main coil stretched" was confirmed 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 during the procedure the subject coil stretched, and the physician was concerned that it might become stuck in the catheter and not be fully removed from the patient.As a result, the subject coil and microcatheter were removed and replaced with a new microcatheter and subject coil.The device was returned for analysis, and the coil delivery wire was found to be kinked/bent.The main coil was noted to be broken/ fractured from detachment zone.It also seemed to be extremely stretched and suture damaged.Analysis confirmed that reported defect was confirmed.Based on the all-available information and analysis of the device it is probable that the subject coil might be pushed/pulled against resistance may cause the reported and analyze defect therefore an assignable cause of 'procedural factors' will be assigned to as reported and as analyzed 'main coil stretched' and to the as analyzed 'main coil broken/fractured during use', and 'main coil suture damage' 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.An assignable cause of 'handling damage' will be assigned to the as analyzed 'coil delivery wire kinked/bent' since this issue is most likely due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.

• Brand Name: TARGET XXL 360 8MM X 20CM
• 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: 24341709
• Report Number: 3008881809-2026-00084
• Device Sequence Number: 21217793
• Product Code: HCG
• UDI-Device Identifier: 07613327466416
• UDI-Public: (01)07613327466416(17)261023(10)24588027
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K242243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/15/2026

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: M0036180820
• Device Lot Number: 24588027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2023
• 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: SL-10 CATHETER (STRYKER).
• Patient Sex: Unknown