MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421020
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 indicated that the coil was inspected before use and no issues were noted, preparation/set-up was performed as per the dfu, continuous flush was maintained for the duration of the procedure, an excelsior microcatheter was used, 2 attempts were made to detach the coil, no thrombus or other embolic agents were present on the detachment zone, the delivery wire and microcatheter markers were verified to be properly aligned under fluoroscopy, and the inzone was maintained in a stable position.Analysis of the returned device revealed the main coil had been detached.Based on visual inspection of the detachment zone, the detachment appeared to be electrolytic in nature.Therefore, the as reported 'main coil failed/unable to detach' was not confirmed.The main coil was noted to be kinked/bent and stretched and the coil delivery wire was noted to be kinked/bent and fractured.It is likely that the damage to the main coil was sustained during manipulation in the microcatheter.An assignable cause of procedural factors will be assigned to the as analyzed (aa) 'main coil kinked/bent' and 'main coil stretched' 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.An assignable cause of handling damage will be assigned to the aa 'coil delivery wire kinked/bent' and 'coil delivery wire broken/fractured during use' since these issues are associated with handling of the device during the clinical procedure.
Event or Problem Description
The subject device was returned for analysis and it was discovered that the coil delivery wire was broken/fractured during use.There was no clinical consequence to the patient reported as a result of this event.

• Brand Name: TARGET 360 NANO 1MM X 2CM
• 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: 13671262
• Report Number: 3008881809-2022-00105
• Device Sequence Number: 4893780
• Product Code: HCG
• UDI-Device Identifier: 04546540697967
• UDI-Public: 04546540697967
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K153658
• 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): 03/04/2022

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 Expiration Date: 12/08/2022
• Device Model Number: M0035421020
• Device Catalogue Number: M0035421020
• Device Lot Number: 22003766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2019
• 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 MICROCATHETER (STRYKER)
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 67 KG