MAUDE Adverse Event Report: Stryker Neurovascular Cork TARGET XXL 360 6MM X 40CM; Device, Neurovascular Embolization

Catalog Number	M0036180640
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was initially reported that during introduction, the subject coil device became stuck within the microcatheter.Subsequent analysis of the returned coil device revealed that it had prematurely detached during use.The subject coil was replaced with a new device, and the procedure was completed successfully with no reported clinical consequences to the patient.
Additional Manufacturer Narrative
Device history record review: 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 analysis, the returned coil device (subject device) revealed that the subject coil delivery wire was kinked/ bent.The main coil was seen to be stretched and within the hub and the suture was damaged.The main coil was seen to be detached.The reported complaint was confirmed during analysis.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 reported event.Based on a review of all available information and the analysis of the returned device it is probable that the subject coil got stretched and got stuck in the catheter hub.This led to the subject coil detaching from the delivery wire.The as reported ¿coil jammed¿ was confirmed based on the analysis and the as reported as well as the as analyzed ¿main coil stretched¿, ¿coil jammed¿, ¿main coil suture damage¿ and ¿main coil prematurely detached/separated during use¿ will be assigned procedural factor 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 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 XXL 360 6MM X 40CM
• 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: 50813662
• Report Number: 3008881809-2026-00582
• Device Sequence Number: 10647892
• Product Code: HCG
• UDI-Device Identifier: 07613327466409
• UDI-Public: (01)07613327466409(17)310208(10)26130740
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• 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): 09/18/2026

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: M0036180640
• Device Lot Number: 26130740
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/13/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2026
• 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 1018 microcatheter (Stryker)
• Patient Age: 75 YR
• Patient Sex: Female