MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 3.0MM X 8.0CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5413080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
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 delivery wire was kinked at 5.5cm from the detachment zone (dz).The main coil was noted to be extensively stretched.The suture was noted to be fractured.The main coil was fractured.There were no anomalies noted to the distal tip of the introducer sheath.A functional test was unable to be performed due to the condition of the returned 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.The reported main coil difficulty inserting and coil in catheter friction were not able to be replicated during analysis; 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.It was reported that the subject coil encountered resistance while transferring the coil from the introducer sheath into the hub of the microcatheter and while advancing the coil within the microcatheter.It was noted that three coils were successfully deployed prior to switching to the subject coil.Additional information provided by the customer indicated that the tapered distal end of the introducer sheath was firmly seated in the hub of the microcatheter (with a slight buckling or reactive force indicating proper positioning), the rotating hemostatic valve (rhv) was adequately tightened while the introducer sheath was in the hub (not over/under-tightened) and was opened enough to allow passage of the device through without damage, excessive force was not applied at any point while advancing the coil within the microcatheter, and the coil was able to move with friction then became stuck.Based on the information provided, the device appeared to have been used as intended.During visual inspection, the coil delivery wire was found to be kinked at 5.5cm from the detachment zone and the main coil was found to be fractured and stretched with suture damage.A functional test was unable to be performed due to the condition of the returned device.The reported events: ¿main coil difficulty inserting¿ and ¿coil in catheter friction¿ were not able to be replicated during analysis, however the analysis results are consistent with the reported event as the damage noted to the coil is indicative of the reported friction.An assignable cause of procedural factors will be assigned to the as reported events: 'main coil difficulty inserting' and 'coil in catheter friction' as well as the as analyzed events: 'coil delivery wire kinked/bent', 'main coil stretched', 'main coil suture damage' and 'main coil broken/fractured during use' since these issues are associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use the product performance was limited.
Event or Problem Description
The coil (subject device) was returned for analysis and was examined.During device investigation and analysis, it was discovered that the coil (subject device) was fractured.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET TETRA 3.0MM X 8.0CM
• 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: 21778839
• Report Number: 3008881809-2025-00189
• Device Sequence Number: 8664428
• Product Code: HCG
• UDI-Device Identifier: 07613327578669
• UDI-Public: (01)07613327578669(17)270325(10)24870908
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/04/2025

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: TG5413080
• Device Lot Number: 24870908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2024
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER); SYNCHRO SELECT GUIDEWIRE (STRYKER)
• Patient Sex: Unknown