MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036123060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a haemostatic embolisation procedure, repeated attempts were made to reposition the subject coil tightly by rewinding it.However, it was confirmed under fluoroscopy that the subject coil would not advance when pulled and it seemed that the subject coil got prematurely detached within the microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D4 expiration date ¿ added d4 gtin ¿ added h4 manufacturing date ¿ added due to the automated mes system, there are controls in the manufacturing process to ensure the product met specifications upon release.The visual and functional inspection could not be performed as the product was not returned for analysis.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 hemostatic embolization when attempting to reposition the target coil, it stretched and separated prematurely inside the microcatheter (mc).The coil was retrieved from the mc, and the procedure was completed using the same mc.It is noted that continuous flush was not set up and maintained throughout the clinical procedure.Also, considerable force was possibly used to retrieve the coil.Both of these factors may have contributed to the reported event.The device was not returned for analysis.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.
Event or Problem Description
It was reported that during a haemostatic embolisation procedure, repeated attempts were made to reposition the subject coil tightly by rewinding it.However, it was confirmed under fluoroscopy that the subject coil would not advance when pulled and it seemed that the subject coil got prematurely detached within the microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XL 360 SOFT 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: 24341620
• Report Number: 3008881809-2026-00083
• Device Sequence Number: 9423361
• Product Code: HCG
• UDI-Device Identifier: 07613327128277
• UDI-Public: (01)07613327128277(17)291129(10)25285529
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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: M0036123060
• Device Lot Number: 25285529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 02/15/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2024
• 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: HIGHFLOW OF LEONISMOVA (UNKNOWN).
• Patient Sex: Unknown