MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035424150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure it was impossible to pass the subject coil through a microcatheter and the subject coil curled and disintegrated inside the microcatheter during the procedure.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.A surgical delay of unknown length was reported.
Additional Manufacturer Narrative
D4 expiration date - added d4 gtin - added h4 manufacturing date ¿ added 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 available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the subject 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 subject coil curled and broke inside of the microcatheter during advancement.The event details indicate that an incorrectly sized microcatheter was used to deliver the subject coil.The max microcatheter internal diameter that is recommended for use with the subject coil is 0.019in.The headway microcatheter which was used has a 0.021in id which is larger than recommended and is likely to have contributed to the reported event.An assignable cause of use error will be assigned to this complaint as the issue investigation confirms that there was an act that resulted in a different medical product response than intended by the manufacturer and/or expected by the user.
Event or Problem Description
It was reported that during procedure it was impossible to pass the subject coil through a microcatheter and the subject coil curled and disintegrated inside the microcatheter during the procedure.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.A surgical delay of unknown length was reported.

• Brand Name: TARGET 360 ULTRA 4MM X 15CM
• 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: 21150414
• Report Number: 3008881809-2025-00038
• Device Sequence Number: 9189854
• Product Code: HCG
• UDI-Device Identifier: 04546540675941
• UDI-Public: (01)04546540675941(17)270918(10)25188537
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K053268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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: M0035424150
• Device Lot Number: 25188537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2024
• 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: HEADWAY 21 MICROCATHETER (NON-STRYKER).
• Patient Sex: Unknown