MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 6MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036126200
Medical Device Problem Code	Fracture (1260)
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 (manufacturing execution system) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the subject coil delivery wire was kinked in numerous areas.The main coil was seen to be stretched, the suture damaged and the main coil fractured.The functional inspection was not applicable.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 "coil in catheter friction¿ 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 while advancing the subject coil through the microcatheter, resistance was encountered, causing the coil to become stuck within the shaft.The coil was retrieved, and the procedure was successfully completed using a new replacement coil of the same type through the same microcatheter.Additional information provided by the customer indicated that friction was encountered at the shaft 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 onfirmed 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, and the coil delivery wire was found to be kinked and bent at several locations.The main coil was observed to be excessively stretched with damage to the sutures and appeared to be broken/fractured.Based on the all-available information and analysis of the device it is probable that the subject coil pushed/pulled against resistance may cause the reported and analyze defect therefore an assignable cause of 'procedural factors' will be assigned to as reported" coil in catheter friction¿, and as analyzed ¿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.An assignable cause of 'handling damage' will be assigned to the as analyzed 'coil delivery wire kinked/bent' since this issue is most likely due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.
Event or Problem Description
The subject coil was returned for analysis, and it was discovered that the subject main coil had appeared to be broken/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 6MM 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: 24430760
• Report Number: 3008881809-2026-00105
• Device Sequence Number: 13338120
• Product Code: HCG
• UDI-Device Identifier: 07613327004625
• UDI-Public: (01)07613327004625(17)261213(10)23373117R
• 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): 02/24/2026

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: M0036126200
• Device Lot Number: 23373117R
• 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: 01/30/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2021
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER).
• Patient Sex: Unknown