MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 4.0MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5414010
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject coil experienced difficulty constructing the coil frame.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.The subject coil was returned for analysis and the device investigation revealed that it was prematurely detached during use.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil delivery wire was not returned.The main coil was seen to be detached and stretched.For functional inspection, memory loss confirmed ¿ visual defects noted (i.E.Kinks, stretches) - no suture removal required the reported event is covered in the device direction 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 was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that the physician experienced difficulty constructing the subject coil frame.Additional information provided by the customer indicated that there were no anomalies noted to the device prior to use.There was no damage noted to the device.The subject coil didn't encounter any resistance during the procedure.During analysis, the subject main coil was noted to be detached and stretched.The coil delivery wire was not returned.It is likely that anatomical factors contributed to the reported event.An assignable cause of procedural factors will be assigned to reported ¿main coil loss of memory¿ as well as analyzed ¿main coil prematurely detached/separated during use¿, ¿main stretched¿ and ¿main coil loss of memory¿ provided in the grid below as the complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.

• Brand Name: TARGET TETRA 4.0MM 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: 24537059
• Report Number: 3008881809-2026-00129
• Device Sequence Number: 18409782
• Product Code: HCG
• UDI-Device Identifier: 07613327578737
• UDI-Public: (01)07613327578737(17)300609(10)25656074
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 03/06/2026

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: TG5414010
• Device Lot Number: 25656074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• 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 (STRYKER)
• Patient Sex: Female