MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035424060
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when inserting the subject coil into the rhv (rotating hemostasis valve) of the microcatheter during an aneurysm coil embolization procedure, the fluoro-saver markers were visible on the coil delivery wire.However, the subject coil had already reached the aneurysm when the fluoroscopy was turned to visualize the coil position.The subject coil was implanted without any issues, the procedure was completed successfully and there were no clinical consequences to the patient due to the reported event.
Event or Problem Description
It was reported that when inserting the subject coil into the rhv (rotating hemostasis valve) of the microcatheter during an aneurysm coil embolization procedure, the fluoro-saver markers were visible on the coil delivery wire.However, the subject coil had already reached the aneurysm when the fluoroscopy was turned to visualize the coil position.The subject coil was implanted without any issues, the procedure was completed successfully and there were no clinical consequences to the patient due to the reported event.
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.The subject device was not returned; therefore, physical as well as functional evaluation could not 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 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.It was reported that the physician observed that the fluoro-saver markers on the subject delivery wire were till outside the microcatheter when the subject coil had already exited the microcatheter distal tip.Additional information provided indicated that an rhv was used and there was no reported subject coil stretching.The subject coil was implanted successfully.A review of the device manufacturing records did not identify any potential cause for the reported event.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.

• Brand Name: TARGET 360 ULTRA 4MM 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: 21590255
• Report Number: 3008881809-2025-00132
• Device Sequence Number: 8479679
• Product Code: HCG
• UDI-Device Identifier: 04546540675910
• UDI-Public: (01)04546540675910(17)280814(10)24484220R
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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,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 Catalogue Number: M0035424060
• Device Lot Number: 24484220R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2023
• 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: SL10 - MICROCATHETER (STRYKER)
• Patient Age: 56 YR
• Patient Sex: Female