MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 1.5MM X 2.0CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5411520
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 2 of 3 reports (2nd mdr).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 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 when the ro marker (radiopacity marker) on the pusher wire was at the appropriate point lined up with the proximal microcatheter marker, it appeared that excess delivery wire was outside of the microcatheter tip.A headway duo (non-stryker) microcatheter was used in the procedure.Additional information provided by the customer indicated that no anomalies were noted to the subject device after removal from the packaging or prior to preparation, the device was prepared as per the dfu, continuous flush was maintained throughout the procedure, the coil was successfully implanted, there was no damage noted to the microcatheter tip, and the microcatheter tip was not shaped by the physician.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 'ro marker band misaligned'.
Event or Problem Description
It was reported that when the ro marker (radiopacity marker) on the pusher wire of the subject coil was at the appropriate point lined up with the proximal microcatheter marker, it appeared excess subject coil delivery wire was outside of the microcatheter tip.The subject device was implanted, and the procedure was completed successfully using additional coils.No additional information available.

• Brand Name: TARGET TETRA 1.5MM X 2.0CM
• 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: 22203923
• Report Number: 3008881809-2025-00337
• Device Sequence Number: 15140123
• Product Code: HCG
• UDI-Device Identifier: 07613327580099
• UDI-Public: (01)07613327580099(17)270427(10)25295150
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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
• Report Date (Section B): 06/13/2025

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: TG5411520
• Device Lot Number: 25295150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2024
• 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 DUO CATHETER (NON-STRYKER)
• Patient Sex: Unknown