MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 7MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036127200
Medical Device Problem Codes	Fracture (1260); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 main coil was found within the microcatheter detached from the delivery wire.The main coil was seen to be fractured.The main coil was severely stretched, and the suture was damaged.The coil delivery wire was not returned.The functional inspection could not be carried out due to damage.The reported 'coil in catheter friction' could not be replicated during device analysis; however, the analysis results are consistent with the reported event.The reported 'main coil stretched' was confirmed.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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.It was reported that 'when the coil was advanced within the microcatheter, it got stuck in the shaft due to resistance.When the coil was retracted, it got stretched within the shaft.' additional information provided by the customer indicated that 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.The device was returned for analysis; the main coil was found within the microcatheter detached from the delivery wire.The main coil was seen to be fractured.The main coil was severely stretched, and the suture was damaged.Based on the information provided, it is probable that anatomical factors may have contributed to the reported event.It is likely that resistance encountered during the procedure caused the coil to become lodged within the shaft, and the application of force against this resistance may have further contributed to the observed condition of the returned device.An assignable cause of procedural factors will be assigned to as reported 'coil in catheter friction', 'main coil stretched' as well as analyzed 'main coil prematurely detached/separated during use', 'main coil broken/fractured during use' , 'main coil stretched' , 'main coil suture damage' 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.
Event or Problem Description
The subject coil was returned for analysis, and it was discovered that the subject main coil was found within the microcatheter detached from the delivery wire and the subject main coil was seen to be fractured.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 XL 360 SOFT 7MM X 20CM
• 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: 24684311
• Report Number: 3008881809-2026-00164
• Device Sequence Number: 9977097
• Product Code: HCG
• UDI-Device Identifier: 07613327004632
• UDI-Public: (01)07613327004632(17)300202(10)25447823
• 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): 03/25/2026

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: M0036127200
• Device Lot Number: 25447823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2025
• 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: SL-10 MICROCATHETER (STRYKER).; TARGET COIL (STRYKER).
• Patient Sex: Unknown