MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 6MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036180620
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when an attempt was made to insert subject coil into a microcatheter, slight resistance was encountered in the shaft, thus, the subject coil was carefully advanced within the shaft; however, the subject coil got prematurely detached in the microcatheter shaft.Since the aneurysm was coiled enough, the prematurely detached coil was removed with the entire microcatheter, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that when an attempt was made to insert subject coil into a microcatheter, slight resistance was encountered in the shaft, thus, the subject coil was carefully advanced within the shaft; however, the subject coil got prematurely detached in the microcatheter shaft.Since the aneurysm was coiled enough, the prematurely detached coil was removed with the entire microcatheter, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual testing as well as functional testing cannot be performed.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 slight resistance was encountered in the shaft, thus, the coil was carefully advancing within the shaft.However, the coil got prematurely detached in the microcatheter shaft.A non-stryker microcatheter was being used.The internal diameter was noted to be compatible with target xxl coils.The coil was removed, and the procedure was completed successfully without inserting another coil.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 of coil in catheter friction, main coil prematurely detached/separated during use.

• Brand Name: TARGET XXL 360 6MM X 20CM
• 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: 23089276
• Report Number: 3008881809-2025-00505
• Device Sequence Number: 21459859
• Product Code: HCG
• UDI-Device Identifier: 07613327466386
• UDI-Public: (01)07613327466386(17)300323(10)25527589
• 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): 10/16/2025

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: M0036180620
• Device Lot Number: 25527589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/29/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2025
• 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: MICROCATHETER (NON-STRYKER).
• Patient Sex: Unknown