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	10/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the procedure there was resistance encountered in the middle of the catheter shaft when the subject coil was advanced.When coiling into the aneurysm, the physician thought the subject coil seemed deformed and broken.The subject coil was removed by pulling the delivery wire.The device was replaced and the procedure was completed successfully with no clinical consequences to the patient.
Event or Problem Description
It was reported during the procedure there was resistance encountered in the middle of the catheter shaft when the subject coil was advanced.When coiling into the aneurysm, the physician thought the subject coil seemed deformed and broken.The subject coil was removed by pulling the delivery wire.The device was replaced and the procedure was completed successfully with no clinical consequences to the patient.
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.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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.It was reported that resistance was encountered when advancing the coil through the microcatheter and when deploying the coil seemed deformed/broken.As the coil was able to be retrieved by pulling back on the delivery wire, it is unlikely that the coil fractured.However, as the device was not returned, this cannot be conclusively determined.The device was confirmed to be in good condition prior to use and was prepared per the dfu.An assignable cause of undeterminable will be assigned to this complaint as the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause.

• 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: 20777641
• Report Number: 3008881809-2024-00565
• Device Sequence Number: 4361801
• Product Code: HCG
• UDI-Device Identifier: 04546540675880
• UDI-Public: (01)04546540675880(17)270617(10)24976402
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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: 24976402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2024
• 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: EXCELSIOR SL-10 CATHETER (STRYKER)
• Patient Sex: Unknown