MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 3.5MM X 6.0CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5413560
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
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 available; therefore, a visual inspection as well as a functional evaluation could not 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 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 when performing the double catheter technique, an attempt was made to place the subject coil in the aneurysm; however, it did not engage with the vessel.Therefore, the coil was retrieved and reinserted into the other microcatheter; however, the coil got prematurely detached within the microcatheter.The coil was removed with the entire microcatheter, a new coil of the same kind was placed, as was a new microcatheter, and the procedure was completed successfully.The type of microcatheters used in the procedure were unknown, and there was no allegation against the microcatheters.Additional information provided by the customer indicated that no anomalies were noted to the device prior to use on the patient, the device was prepared for use as per the directions for use, continuous flush was set up and maintained throughout the clinical procedure, the tapered distal end of the introducer sheath was firmly seated in the hub of the microcatheter, the rhv (rotating hemostasis valve) was adequately tightened while the introducer sheath was in the hub (not over/under-tightened) and was opened enough to allow passage of the device through without damage, the lumen of the catheter was within the recommended range, and the coil was advanced slowly and carefully without excessive force.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, a cause of undeterminable will be assigned to the as reported 'device difficulty engaging target vessel' and 'main coil prematurely detached/separated during use'.
Event or Problem Description
It was reported that the double catheter technique was performed.Attempted to place the subject coil in the aneurysm; however, it did not engage with the vessel.Therefore, the subject coil was retrieved and reinserted into the other microcatheter; however, it got prematurely detached within the microcatheter.The subject coil was removed with the entire microcatheter.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET TETRA 3.5MM X 6.0CM
• 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: 24301677
• Report Number: 3008881809-2026-00074
• Device Sequence Number: 20137407
• Product Code: HCG
• UDI-Device Identifier: 07613327578683
• UDI-Public: (01)07613327578683(17)260925(10)24545886
• 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
• Type of Report: Initial
• Report Date (Section B): 02/10/2026

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 Expiration Date: 09/25/2026
• Device Catalogue Number: TG5413560
• Device Lot Number: 24545886
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2023
• 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: MICROCATHETER (UNKNOWN)
• Patient Sex: Unknown