MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 3.0MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5413010
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection, the coil delivery wire was noted to be kinked/bent.The main coil was seen to be kinked and detached/separated.The coil introducer sheath was not returned.The reported event could not be replicated during device analysis; however, the analysis results are consistent with the reported event.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.It was reported that the subject coil would not detach and continued to be taking long time.The physician then changed the power supply to detach the coil, and it worked successfully.The device was returned for analysis.The coil delivery wire was found to be kinked/bent.The main coil was also observed to be kinked and detached from delivery wire.The coil introducer sheath was not returned.Based on the available information and analysis of the device, there is no definitive evidence to support the reported event main coil failed/unable to detach.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.It is probable that the subject coil pushed/pulled against resistance may cause the analyzed defect therefore an assignable cause of 'procedural factors' will be assigned to main coil prematurely detached/separated during use and main coil kinked/bent as this 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.An assignable cause of ¿handling damage¿ will be assigned to the analyzed coil delivery wire kinked/bent this issue is most likely due to handling of the product or a portion of the product during the clinical procedure, upon removal from the packaging, or during preparation prior to use.
Event or Problem Description
The subject coil was returned for analysis and the device investigation revealed that the subject main coil prematurely detached/separated during use.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: TARGET TETRA 3.0MM 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: 25113483
• Report Number: 3008881809-2026-00282
• Device Sequence Number: 18706827
• Product Code: HCG
• UDI-Device Identifier: 07613327578676
• UDI-Public: (01)07613327578676(17)300628(10)25702562
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 05/07/2026

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: TG5413010
• Device Lot Number: 25702562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2025
• 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: INZONE POWER SUPPLY (STRYKER)
• Patient Sex: Unknown