MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 24MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036182450
Medical Device Problem Codes	Fracture (1260); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil (subject device) was used in the medical procedure.However, resistance was encountered when the coil was inserted in the microcatheter and during its advancement near the tip of microcatheter.The physician attempted to retrieve the coil leading to detachment within the microcatheter.An attempt was made to push and place the detached coil however it could not be pushed forward.The main coil was reported to be stretched, and the coil delivery wire was noted to be fractured.The subject device was replaced along with the microcatheter, and 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 events could not be confirmed and it cannot be confirmed that the device met specification, as the device was not returned.It was reported that there was slight friction upon insertion of the subject coil into the renegade catheter.Resistance increased near the catheter tip.During an attempt to retrieve the coil, it separated from the delivery wire.The patient's anatomy was noted to be of average tortuosity.Continuous flush was not maintained which can contribute to friction during advancement.Per the device ifu, "target xxl detachable coils are compatible with stryker neurovascular 2-tip marker microcatheters with a 0.48 mm [0.019 in] internal diameter." renegade has an internal diameter of 0.021" which is larger than recommended.Based on review of all available information an assignable cause of use error will be assigned to this complaint as the investigation confirms that there was the use of an incorrectly sized product; 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
It was reported that the coil (subject device) was used in the medical procedure.However, resistance was encountered when the coil was inserted in the microcatheter and during its advancement near the tip of microcatheter.The physician attempted to retrieve the coil leading to detachment within the microcatheter.An attempt was made to push and place the detached coil however it could not be pushed forward.The main coil was reported to be stretched, and the coil delivery wire was noted to be fractured.The subject device was replaced along with the microcatheter, and the procedure was completed successfully.No clinical consequences were reported to the patient.

• Brand Name: TARGET XXL 360 24MM 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: 23834563
• Report Number: 3008881809-2025-00726
• Device Sequence Number: 21154179
• Product Code: HCG
• UDI-Device Identifier: 07613327128376
• UDI-Public: (01)07613327128376(17)300819(10)25788600
• 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): 03/18/2026

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: M0036182450
• Device Lot Number: 25788600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2025
• 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: RENEGADE CATHETER (STRYKER).
• Patient Sex: Unknown