MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 2.0MM X 4.5CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5412045
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the subject coil prematurely deployed inside the microcatheter during a balloon-assisted coiling procedure for a ruptured aneurysm.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D10 product available to stryker / returned to manufacturer on ¿ updated h3 device evaluated by mfg ¿updated.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection: was performed as the subject device was returned with an sl-10 microcatheter.The subject main coil was seen to be detached.Functional testing could not be performed due to the condition of the returned device the reported 'main coil prematurely detached/separated during use' was confirmed during analysis.The reported 'coil in catheter friction' could not be replicated due to the condition of the returned subject device; however, the analysis results were 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.It was reported that the subject coil would not advance, and it deployed inside the microcatheter (sl-10) during a balloon assisted coiling case for a ruptured aneurysm.The subject device was returned with an sl-10 microcatheter.Only the delivery wire was received as it was observed that the main coil had been prematurely detached, confirming the reported event.Functional testing could not be performed due to the condition of the returned device.Although the reported 'coil in catheter friction' could not be replicated, the analysis results were consistent with the reported event.Based on visual inspection of the delivery wire, the main coil appeared to have been mechanically detached at the detachment zone.It is likely that this occurred due to advancing/retracting the device against the reported resistance in the catheter.Based on the concurrent complaint investigation for the sl-10 microcatheter, the main coil was found to be stuck inside the microcatheter shaft and could not be removed despite cutting the catheter shaft and several attempts to release the coil.No other anomalies were noted to the microcatheter.An assignable cause of procedural factors will be assigned to the as reported and as analyzed 'main coil prematurely detached/separated during use' as well as the as reported 'coil in catheter friction' since these issues are 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 and/or anatomical factors during use.
Event or Problem Description
It was reported that the subject coil prematurely deployed inside the microcatheter during a balloon-assisted coiling procedure for a ruptured aneurysm.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET TETRA 2.0MM X 4.5CM
• 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: 22867680
• Report Number: 3008881809-2025-00458
• Device Sequence Number: 9359383
• Product Code: HCG
• UDI-Device Identifier: 07613327578591
• UDI-Public: (01)07613327578591(17)270305(10)24840470
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 10/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: TG5412045
• Device Lot Number: 24840470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• 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: SL 10 CATHETER (STRYKER).; SYNCHRO GUIDEWIRE (STRYKER).; TARGET COILS (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown