MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035423100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) 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 seen to be kinked/bent.The subject main coil was seen to be broken and not returned.The subject coil introducer sheath was not returned.The functional inspection was unable to perform due to missing coil.The reported event is covered in the device direction 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 and ¿main coil stretched¿ could not confirmed during analysis as subject main coil was not returned.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that during a subject coil embolization procedure, the physician placed a microcatheter over a guidewire at an aneurysm measuring approximately 3.0 mm to 3.6 mm.The subject coil was initially selected.Upon unpacking and hydration, the subject coil appeared intact.After advancing the subject coil through the microcatheter, the physician encountered resistance when the subject coil was approximately halfway deployed.Despite multiple attempts to advance it further, the subject coil could not be advanced and was subsequently withdrawn.Upon removal, the physician observed that the subject coil had become stretched to successfully complete the procedure, the physician used a new coil, which was deployed through the original microcatheter.Additional information provided by the customer indicated that when advancing the subject coil, operator proceeded slowly and carefully without excessive force.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.The device was returned for analysis, and the subject coil delivery wire was found to be kinked and bent.The subject main coil was observed to be broken and fractured from the delivery wire and was not returned with the device.Due to the condition of the returned device, functional testing could not be performed.During the analysis, the subject coil was found to be missing therefore, an assignable cause of 'not confirmed' has been assigned to the reported defect ¿main coil stretched.¿ an assignable cause of 'procedural factors' will be assigned to the reported event ¿coil in catheter friction" it could not be replicated during device analysis; however, the analysis results are consistent with the reported event.It is probable that the subject coil was advanced or retracted against resistance, which may have resulted in fracture of the coil and led to the observed defects in the device.An assignable cause of 'procedural factors' will be assigned to "main coil broken/fractured 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.An assignable cause of 'handling damage' will be assigned to the analyzed defect ¿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
It was reported that during a left posterior communicating artery (pcoma) aneurysm coil embolization procedure, when the subject coil was pushed to approximately the halfway point of the microcatheter, the physician found that it could not be advanced further.When withdrawn outside the body, the physician found that the coil had been stretched.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.The subject device was returned for analysis and the device investigation revealed that the subject main coil was broken/fractured during use.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 ULTRA 3MM X 10CM
• 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: 24868058
• Report Number: 3008881809-2026-00220
• Device Sequence Number: 12999799
• Product Code: HCG
• UDI-Device Identifier: 04546540675903
• UDI-Public: (01)04546540675903(17)300511(10)25609234
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 04/14/2026

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: M0035423100
• Device Lot Number: 25609234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2025
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER); GUIDEWIRE
• Patient Age: 58 YR
• Patient Sex: Unknown
• Patient Race: Asian