MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421540
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure of venous sinus emboli of dural-avf, the coil (subject device) was advanced into the microcatheter, but there was strong resistance about 10 cm before the tip of the catheter, so it was retrieved.While retrieving the coil (subject device) , it got prematurely detached at the rhv(rotating hemostasis valve).The detached coil (subject device) was safely removed from the patient¿s anatomy by removing the rhv.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
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.Visual inspection of the subject coil device revealed the main coil was found to be detached/separated.Additionally, the core delivery wire was found to be kinked/ bent.The coil introducer sheath was not returned.The functional testing could not be performed due to the condition of the returned device.An assignable cause of procedural factors will be assigned to the reported and as analysed ' coil in catheter friction', as the issues are associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited the reported 'main coil prematurely detached/separated during use' was confirmed during the analysis.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.As the main coil was found to be prematurely detached/separated and the coil delivery wire was found to be kinked/bent.Therefore, an assignable cause of procedural factors will be assigned to the reported and as analysed ¿ main coil prematurely detached/separated during use¿, as the issues are associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.A probable cause of handling damage was assigned to the analysed ¿coil delivery wire kinked/bent as the defect appears to be associated with handling of the product or portion of the product during the procedure.
Event or Problem Description
It was reported that during procedure of venous sinus emboli of dural-avf, the coil (subject device) was advanced into the microcatheter, but there was strong resistance about 10 cm before the tip of the catheter, so it was retrieved.While retrieving the coil (subject device) , it got prematurely detached at the rhv(rotating hemostasis valve).The detached coil (subject device) was safely removed from the patient¿s anatomy by removing the rhv.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET 360 NANO 1.5MM X 4CM
• 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: 15795255
• Report Number: 3008881809-2022-00569
• Device Sequence Number: 3010266
• Product Code: HCG
• UDI-Device Identifier: 04546540697998
• UDI-Public: 04546540697998
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 12/12/2022

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: 05/08/2025
• Device Model Number: M0035421540
• Device Catalogue Number: M0035421540
• Device Lot Number: 236839151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2022
• 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: PHENOM17 MICROCATHETER(NON-STRYKER)
• Patient Sex: Prefer Not To Disclose