MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 2MM X 4CM; Device, Neurovascular Embolization

Catalog Number	M0035472040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during the procedure when the subject coil was being delivered in aneurysm, it prematurely detached.A stent retriever and snare were used to retrieve the detached coil but were unsuccessful.The physician used an aspiration catheter and snare to remove the coil successfully without compromising the aneurysm.The procedure was completed.No other information is available.

• Brand Name: TARGET 360 SOFT 2MM 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 ; +1(510)413-2500
• MDR Report Key: 25518155
• Report Number: 3008881809-2026-00370
• Device Sequence Number: 15993754
• Product Code: HCG
• UDI-Device Identifier: 07613252192701
• UDI-Public: (01)07613252192701(17)300526(10)25636538
• 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: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: M0035472040
• Device Lot Number: 25636538
• Date Returned to Manufacturer: 06/08/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2026
• Supplement Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 06/16/2026
• Supplement Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2025
• 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: ASPIRATION CATHETER (UNKNOWN); EXCELSIOR XT-17 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female