MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035423060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 delivery wire was seen to be severely kinked/bent.The main coil was seen to be stretched.The coil suture was seen to be damaged.The main coil was seen to be broken/fractured.A functional test was unable to perform due to damage.The reported 'main coil kinked/bent' was confirmed during visual inspection.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 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 complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that resistance was experienced while advancing the subject coil within the microcatheter.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared for use as per the dfu, continuous flush was set up and maintained throughout the clinical procedure.The tapered distal end of the introducer sheath was firmly seated in the hub of the microcatheter, the rhv (rotating hemostatic valve) was adequately tightened while the introducer sheath was in the hub and was opened enough to allow passage of the device through without damage.A bit of force was experienced while advancing.Based on the review of all available information, an assignable cause of procedural factors will be assigned to as reported 'coil in catheter friction' and 'main coil kinked/bent' as well as analyzed, 'main coil stretched', 'main coil suture damage' and '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 as analyzed 'coil delivery wire kinked/bent' since it is most likely that this damage occurred due to handling of delivery wire during the clinical procedure.
Event or Problem Description
The coil (subject device) was returned for analysis and it was discovered that the coil (subject device) was broken/fractured during use.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 3MM X 6CM
• 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: 21114133
• Report Number: 3008881809-2025-00028
• Device Sequence Number: 8760714
• Product Code: HCG
• UDI-Device Identifier: 04546540675880
• UDI-Public: (01)04546540675880(17)270618(10)24987382
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K120850
• 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): 01/09/2025

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: M0035423060
• Device Lot Number: 24987382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2024
• 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: SL-10 CATHETER (STRYKER)
• Patient Age: 55 YR
• Patient Sex: Female