MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 22MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036182250
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil (subject device) was used in the medical procedure.However, when the coil was inserted into the microcatheter it got stuck at the distal end of the microcatheter.The physician attempted to retrieve the coil and the coil got stretched and detached prematurely within the shaft of microcatheter.The subject device was replaced along with the microcatheter.The procedure was completed successfully no clinical consequences were reported to the patient.
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 event 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not returned.It was reported that there was resistance when advancing the coil inside the microcatheter.When the coil was retracted it got stretched and it prematurely detached.The coil was removed together with the microcatheter.After that, the procedure was completed successfully.No anomalies were noted to the device prior to use.Based on the additional information intermittent flush was maintained instead of the recommended continuous flush.Per the dfu, "in order to achieve optimal performance of the 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 coil".Based on the review of all available information, an assignable cause of use error will be assigned to this event.The investigation confirms that there was an act or omission of an act that resulted in a different medical product response than intended by the manufacturer and/or expected by the user.
Event or Problem Description
It was reported that the coil (subject device) was used in the medical procedure.However, when the coil was inserted into the microcatheter it got stuck at the distal end of the microcatheter.The physician attempted to retrieve the coil and the coil got stretched and detached prematurely within the shaft of microcatheter.The subject device was replaced along with the microcatheter.The procedure was completed successfully no clinical consequences were reported to the patient.

• Brand Name: TARGET XXL 360 22MM X 50CM
• 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: 23174670
• Report Number: 3008881809-2025-00523
• Device Sequence Number: 9555534
• Product Code: HCG
• UDI-Device Identifier: 07613327128369
• UDI-Public: (01)07613327128369(17)291112(10)25268405
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: M0036182250
• Device Lot Number: 25268405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2024
• 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