MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 7MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035477200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the basilar artery aneurysm procedure, the subject coil was broken while advancing within the microcatheter prior to the deployment.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
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/microscopic inspection, the coil delivery wire kinked/bent.The main coil was found to be severely stretched.The main coil suture was found to be damaged.There was no coil breakage noted.During functional inspection, main coil broken/fractured during use functional test was not applicable.The defect was not confirmed during visual inspection.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 complaint was not confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.During analysis, the main coil was found to be severely stretched, the main coil suture was found to be damaged, and the coil delivery wire was found to be kinked/bent.An assignable cause of not confirmed will be assigned to the as reported ¿main coil broken/fractured during use¿ as the defect was not confirmed during the analysis.An assignable cause of procedural factors will be assigned to as analyzed ¿main coil stretched¿, ¿main coil suture damage¿ as these defects 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 as analyzed 'coil delivery wire kinked/bent' since it is most likely that this damage occurred due to handling of delivery wire during the clinical procedure.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that during the basilar artery aneurysm procedure, the subject coil was broken while advancing within the microcatheter prior to the deployment.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 SOFT 7MM X 20CM
• 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: 15291337
• Report Number: 3008881809-2022-00410
• Device Sequence Number: 20624698
• Product Code: HCG
• UDI-Device Identifier: 04546540676573
• UDI-Public: 04546540676573
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 10/24/2022

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: 06/09/2024
• Device Model Number: M0035477200
• Device Catalogue Number: M0035477200
• Device Lot Number: 22902527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2022
• Supplement Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2021
• 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: ECHELON 10 MICROCATHETER (MEDTRONIC); NEUROFORM ATLAS STENT SYSTEM (STRYKER)
• Patient Sex: Unknown