MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 4MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036124080
Medical Device Problem Codes	Fracture (1260); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
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.During visual inspection, the coil delivery wire was seen to be kinked.The main coil was seen to be detached/separated.The main coil was seen to be broken/fractured and stretched.The main coil suture was damaged.The coil introducer sheath was intact.A functional evaluation could not be performed due to 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 events of ¿coil in catheter friction¿, ¿main coil difficulty inserting¿ and ¿coil introducer sheath friction¿ was not confirmed due it could not be replicated during device analysis; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that the subject coil encountered resistance while being advanced through the microcatheter.After being retracted into the introducer sheath and reinserted, resistance was again experienced at the same position.The procedure was successfully completed by replacing the coil with a new one from a different lot number and using a same microcatheter.Additional information provided by the customer indicated that there was friction while the coil was advancing the introducer sheath.When advancing the coil, operator proceeded slowly and carefully without excessive force.Friction was encountered at the shaft and hub of the catheter.The tapered distal end of the introducer sheath was firmly seated in the hub of the microcatheter.The device was prepared for use as per the dfu.There was no damage noted to the packaging prior to opening the packaging.The device was confirmed to be in good condition during preparation/ prior to use on the patient.Continuous flush was set up and maintained throughout the clinical procedure.During the analysis, the coil delivery wire was found to be kinked and bent.The main coil also seems to be broken/fractured, stretched, suture damage, and had premature detachment/separation.Based on review of all available information an assignable cause of procedural factors will be assigned to the reported events of ¿coil introducer sheath friction, coil in catheter friction, and main coil difficulty inserting¿ as they could not be replicated during analysis however, the analysis results are consistent with the reported event as the damage to the main coil is indicative of a device that was advanced against resistance.It is probable that the subject coil experienced friction during advancement due to procedural factors during use which resulted in the analyzed defects noted to the device.An assignable cause of 'procedural factors' will be assigned to the analyzed events of ¿main coil broken/fractured during use¿ ,¿main coil stretched¿, ¿main coil suture damage¿, and ¿main coil prematurely detached/separated during use¿ as this 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.It is possible that the delivery wire may have been kinked as a result of pushing or pulling the wire against the reported resistance.An assignable cause of 'handling damage' will be assigned to the analyzed event of ¿coil delivery wire kinked/bent¿ as the defect appears to be associated with handling of the product or portion of the product during preparation.
Event or Problem Description
The coil (subject device) was reported for encountering resistance while advancing from the introducer sheath into the microcatheter and through the microcatheter.However, when the subject device was returned for analysis, it was found that the coil delivery wire was kinked, the main coil was stretched and had suture damage.Also, the main coil was found to be prematurely detached during use and was broken/fractured during use.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient.

• Brand Name: TARGET XL 360 SOFT 4MM X 8CM
• 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: 23585682
• Report Number: 3008881809-2025-00641
• Device Sequence Number: 13137823
• Product Code: HCG
• UDI-Device Identifier: 07613327128390
• UDI-Public: (01)07613327128390(17)270717(10)25068714
• 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
• Report Date (Section B): 11/18/2025

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: M0036124080
• Device Lot Number: 25068714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2024
• 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: CARNELIAN MARVEL MICROCATHETER (NON-STRYKER).
• Patient Sex: Unknown