MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 3.5MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035473510
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during procedure; the subject coil was stuck in the middle of microcatheter as the subject coil could not be pushed forward and the subject coil was prematurely detached in the half body of the microcatheter.The subject coil was removed and replaced with a new coil.The procedure was completed successfully without any clinical consequences to the patient.
Additional Manufacturer Narrative
Section b1 adverse event/product problem - corrected - no product problem.Section h1 type of reportable event - corrected - no malfunction.H3 device evaluated by mfg ¿updated.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 main coil was seen to be kinked.A functional testing could not be carried out due to the damage.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 coil in catheter friction could not be replicated; however, the analysis results are consistent with the reported event.The reported main coil prematurely detached/separated during use was not confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer is, the physician reported the fact that the target coil is stuck in the middle of the microcatheter body, it has been repeated many times and it is still the same.An assignable cause of not confirmed will be assigned to the as reported 'main coil prematurely detached/separated during use' as the defect was not confirmed during analysis.An assignable cause of procedural factors will be assigned to the as reported 'coil in catheter friction' these defects 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 procedural factors will be assigned to the as analyzed 'main coil kinked/bent' these defects 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 manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported during procedure; the subject coil was stuck in the middle of microcatheter as the subject coil could not be pushed forward and the subject coil was prematurely detached in the half body of the microcatheter.The subject coil was removed and replaced with a new coil.The procedure was completed successfully without any clinical consequences to the patient.

• Brand Name: TARGET 360 SOFT 3.5MM X 10CM
• 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: 23324374
• Report Number: 3008881809-2025-00564
• Device Sequence Number: 10612779
• Product Code: HCG
• UDI-Device Identifier: 04546540714770
• UDI-Public: (01)04546540714770(17)300429(10)25592025
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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,Followup
• Report Date (Section B): 11/21/2025

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: M0035473510
• Device Lot Number: 25592025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• 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: ECHELON (EV3) MICROCATHETER
• Patient Age: 41 YR
• Patient Sex: Female