MAUDE Adverse Event Report: Stryker Neurovascular Cork TARGET TETRA 2.5MM X 6.0CM; Device, Neurovascular Embolization

Catalog Number	TG5412560
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject coil advanced through the microcatheter into the middle meningeal artery (mma) but the subject coil would not deploy.However, the subject coil was returned for analysis and the device investigation revealed that the main coil prematurely detached/separated during use.There is no additional information available.
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 inspection the coil delivery wire was kinked.The main coil was seen to be detached and not returned.The main coil was not returned so the functional inspection could not be carried out.The reported event ¿main coil failed/unable to detach could not be replicated¿; 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 on 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.During the procedure, the coil was advanced through the microcatheter into the middle meningeal artery (mma) as usual; however, it failed to deploy.A different power supply was tried, but the coil still did not deploy.The device was returned for analysis.The coil delivery wire was found to be kinked/bent.The main coil was observed detached and not returned.Main coil failed/unable to detach could not be replicated; however, the analysis results are consistent with the reported event.Based on the available information and device analysis, it is probable that kinking of the coil delivery wire near the proximal contact contributed to the detachment failure.Additionally, it is probable that manipulation of the subject coil against resistance during advancement and withdrawal led to coil detachment.Therefore an assignable cause of 'procedural factors' will be assigned to the reported event ¿main coil failed/unable to detach¿ and to the analysed event ¿coil delivery wire kinked/bent¿ and ¿main coil prematurely detached/separated during use¿ 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.

• Brand Name: TARGET TETRA 2.5MM 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 ; +1(510)413-2500
• MDR Report Key: 50819212
• Report Number: 3008881809-2026-00583
• Device Sequence Number: 10713075
• Product Code: HCG
• UDI-Device Identifier: 07613327578638
• UDI-Public: (01)07613327578638(17)310206(10)26131064
• Combination Product (Y/N): N
• 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): 09/18/2026

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: TG5412560
• Device Lot Number: 26131064
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/23/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2026
• 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: Target coil (Stryker)
• Patient Sex: Unknown