MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 5MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035425100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, when advancing the subject coil through the microcatheter, the subject coil got stuck in the middle of the microcatheter shaft and when an attempt was made to retrieve it, the subject coil become stuck in the microcatheter shaft and the delivery wire broke inside the microcatheter shaft.The entire microcatheter was retrieved.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the main coil was returned jammed into the non-stryker microcatheter.The coil delivery wire was not returned.There was dried procedural fluid found on the outside and the inside the microcatheter.During a functional inspection, the microcatheter was cut in multiple areas in attempt to remove the coil, however it could not be removed.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 jammed was confirmed during the analysis.The reported coil delivery wire broken/fractured during use was could not be confirmed based on analysis as the delivery wire wasn¿t 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 while advancing the coil through the microcatheter, it got stuck midway.An attempt to retrieve it caused the coil to remain lodged in the shaft, and the delivery wire broke off inside.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.There was no resistance when the coil was taken out of the dispenser hoop.There was no friction noted while the coil was advancing the introducer sheath.The tapered distal end of the introducer sheath was firmly seated in the hub of the microcatheter.The delivery was reported to be damaged at the distal part.An assignable cause of 'undeterminable' will be assigned to as reported 'coil delivery wire broken/fractured during use' as the delivery wire wasn¿t returned.An assignable cause of 'procedural factors' will be assigned to as reported as well as analyzed 'coil jammed' as the 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
It was reported that during the procedure, when advancing the subject coil through the microcatheter, the subject coil got stuck in the middle of the microcatheter shaft and when an attempt was made to retrieve it, the subject coil become stuck in the microcatheter shaft and the delivery wire broke inside the microcatheter shaft.The entire microcatheter was retrieved.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 360 ULTRA 5MM 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: 21327693
• Report Number: 3008881809-2025-00070
• Device Sequence Number: 18121382
• Product Code: HCG
• UDI-Device Identifier: 04546540675958
• UDI-Public: (01)04546540675958(17)250803(10)23792781
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2025

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 Expiration Date: 08/03/2025
• Device Catalogue Number: M0035425100
• Device Lot Number: 23792781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2022
• 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: MICROCATHETER (UNKNOWN)
• Patient Sex: Unknown