MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4.5MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035424510
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during coil embolization of anterior communicating (a-com) artery ruptured aneurysm procedure; the subject coil was used as the first coil.Although the coil was repositioned, it did not engage with the vessel.Thus, the operator attempted to retract the subject coil, however, the subject coil was retracted in the opposite side of the introducer sheath.The microcatheter was advanced to the aneurysm, and the subject coil was inserted with strong resistance.The operator pushed the coil hard, which resulted in premature detachment of the subject coil within the microcatheter's shaft.The subject coil was removed with the entire microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added d4 expiration date - added d4 gtin - updated due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional inspections were not conducted due to the device 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.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.It was reported that during the coil embolization procedure of an anterior communicating (a-com) ruptured aneurysm, the coil did not engage with the vessel.The coil was retracted so that the catheter tip could be shaped.When the coil was being advance again, it was advance against strong resistance and the coil detached within the microcatheter.The coil was removed with the entire microcatheter and replaced with a new one of the same size, and the procedure was completed successfully using a new microcatheter.It is likely that the coil was damaged when retracting it into the opposite side of the sheath and then separated when reintroducing due to the damage and the resistance when advancing.However as the device was not returned, this cannot be confirmed.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 to the reported events: ¿coil introducer sheath friction¿, ¿device difficulty engaging target vessel¿, ¿main coil prematurely detached/separated during use¿.
Event or Problem Description
It was reported that during coil embolization of anterior communicating (a-com) artery ruptured aneurysm procedure, the subject coil was used as the first coil.Although the coil was repositioned, it did not engage with the vessel.Thus, the operator attempted to retract the subject coil, however, the subject coil was retracted in the opposite side of the introducer sheath.The microcatheter was advanced to the aneurysm, and the subject coil was inserted with strong resistance.The operator pushed the coil hard, which resulted in premature detachment of the subject coil within the microcatheter's shaft.The subject coil was removed with the entire microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 ULTRA 4.5MM 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: 22820138
• Report Number: 3008881809-2025-00450
• Device Sequence Number: 5738961
• Product Code: HCG
• UDI-Device Identifier: 04546540714763
• UDI-Public: (01)04546540714763(17)260905(10)24521448
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/17/2025

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 Expiration Date: 09/05/2026
• Device Catalogue Number: M0035424510
• Device Lot Number: 24521448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2023
• 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
• Patient Sex: Unknown