MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 3.0MM X 6.0CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5413060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
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.Visual/microscopic inspection was performed as the main coil (subject device) was returned detached.There were no anomalies noted to the main coil.Functional inspection was not performed as the coil (subject device) was returned detached.The reported complaint ¿main coil failed/unable to detach ¿could not be confirmed; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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.Additional information provided by the customer stated that after three beeps sounded, pulled the coil delivery wire; however, the coil (subject device) was not detached.Another attempt was made to detach it; nevertheless, the same thing occurred.The subject coil was removed from the body and replaced with another size, then this new coil could be detached using the same detachment device.During analysis, the main coil (subject device) was seen to be detached.No other anomalies noted.The main coil (subject device) could have detached while retracting from the micro catheter.An assignable cause of procedural factors will be assigned to the reported event ¿main coil failed/unable to detach¿ these defects appear 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.An assignable cause of procedural factors will be assigned to the as analyzed ¿main coil prematurely detached/separated¿ during use these defects appear 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.
Event or Problem Description
The subject device was returned for analysis, and it was discovered that the subject coil was prematurely detached/separated during use.The subject device was reported to be removed from the body and replaced with another size.The procedure was reported to be completed successfully.No clinical consequences were reported to the patient.

• Brand Name: TARGET TETRA 3.0MM 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: 24942520
• Report Number: 3008881809-2026-00235
• Device Sequence Number: 12178466
• Product Code: HCG
• UDI-Device Identifier: 07613327578652
• UDI-Public: (01)07613327578652(17)270422(10)24870345
• 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
• Report Date (Section B): 04/21/2026

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: TG5413060
• Device Lot Number: 24870345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• 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: INZONE DETACHMENT DEVICE (STRYKER).; MICROCATHETER (UNKNOWN MANUFACTURER).
• Patient Sex: Unknown