MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035422060
Medical Device Problem Codes	Premature Separation (4045); Poor Visibility (4072)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the subject was loaded into the microcatheter, and the subject coil was unable to be seen under fluoroscopy as the pusher wire was advanced, and furthermore the subject coil was detached inside the microcatheter.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
D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.H3 device evaluated by mfg ¿updated.Due to the automated mes system, there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the subject coil delivery wire was seen to be kinked.The main coil was seen to be severely stretched, the suture was missing, the main coil was fractured with the distal end not returned.The target coil was visible under fluoroscopy.The functional inspection was not applicable.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 prematurely detached/separated during use¿ was not confirmed during analysis, and the reported event ¿device or device component not visible under fluoroscopy¿ it could not be replicated during device analysis; however, the analysis results are consistent with the reported event and 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, when the physician advanced the subject coil through the echelon microcatheter, the coil was not visible under fluoroscopy as it was being advanced with the delivery wire.To successfully complete the surgery, the physician removed the coil and replaced it with a new microcatheter and a new coil set.Additional information from the customer indicated that the physician initially believed the subject coil had detached prematurely, which is why it was not observed under fluoroscopy.However, further investigation revealed that the coil remained intact with the delivery wire.Therefore, an assignable cause of not confirmed will be assigned to the event as reported ¿main coil prematurely detached/separated during use.¿ in addition, the coil was not stuck and was able to move freely without any friction during advancement.The device was returned for analysis, and the coil delivery wire was found to be kinked/bent.The main coil was observed to be severely stretched, and it also appeared to be broken and fractured at the distal end and coil was visible under fluoroscopy.Additionally, the coil suture was missing.Due to the condition of the returned device, no functional testing was performed.Based on all available information and the analysis of the returned device, there is no conclusive evidence identifying the exact cause of the reported event as reported ¿device or device component not visible under fluoroscopy.¿ however, it is probable that the event may have occurred due to unknown anatomical and procedural factors during the procedure.Therefore, an assignable cause of procedural factors will be assigned to the reported event.In addition, procedural factors will also be assigned to as analyzed ¿main coil broken/fractured during use¿ ,¿main coil stretched¿ and ¿main coil suture damaged¿ as the analyzed damage probably cause when a device was pulled against resistance during retrieval as 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.
Event or Problem Description
It was reported that during procedure, the subject was loaded into the microcatheter, and the subject coil was unable to be seen under fluoroscopy as the pusher wire was advanced, and furthermore the subject coil was detached inside the microcatheter.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 ULTRA 2MM X 6CM
• 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: 23819001
• Report Number: 3008881809-2025-00712
• Device Sequence Number: 9409390
• Product Code: HCG
• UDI-Device Identifier: 07613252239345
• UDI-Public: (01)07613252239345(17)300607(10)25662414
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K242243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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: M0035422060
• Device Lot Number: 25662414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2025
• 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 MICROCATHETER (UNKNOWN).
• Patient Sex: Unknown