MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 4.0MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5414010
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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 complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.It was reported that the subject coil prematurely detached within the microcatheter shaft.The specific location of premature detachment was unknown.The coil was retrieved within the entire microcatheter, and the procedure was completed successfully with the same microcatheter and a new coil.Based on a review of additional information provided by the customer, it was noted that flush was intermittent during the procedure.In the case of this complaint, it is probable that lack of continuous flush contributed to the reported event.Per the dfu, "in order to achieve optimal performance of the target detachable coil system and to reduce the risk of thromboembolic complications, it is critical that a continuous infusion of appropriate flush solution be maintained between a) the femoral sheath and guide catheter or long sheath, b) the 2-tip microcatheter and guide catheter or long sheath, and c) the 2-tip microcatheter and guidewire and delivery wire.Continuous flush also reduces the potential for thrombus formation on, and crystallization of infusate around, the detachment zone of the target detachable coil." based on the review of all available information, an assignable cause of use error will be assigned to this complaint since there was a deviation from the supplied dfu that resulted in a different medical product response than intended by the manufacturer or expected by the user.
Event or Problem Description
The coil (subject device) was used in the medical procedure.However, resistance was encountered while advancing the coil through the catheter and the coil got prematurely detached/separated within 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 TETRA 4.0MM 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: 23354662
• Report Number: 3008881809-2025-00575
• Device Sequence Number: 15669512
• Product Code: HCG
• UDI-Device Identifier: 07613327578737
• UDI-Public: (01)07613327578737(17)270709(10)25030021
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K242243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

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: TG5414010
• Device Lot Number: 25030021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2024
• 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: MICROCATHETER (UNKNOWN).
• Patient Sex: Unknown