MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035424080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Analysis of the returned device found that the subject coil broke/fractured during use.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully.
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.During visual inspection, the coil delivery wire was found to be kinked/bent and the main coil was found to be broken/fractured.Functional inspection could not be performed as the main coil was not returned.The reported event of coil in catheter friction was not confirmed during analysis; however, the analysis results are consistent with the reported event.The device did not meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The device was analyzed and the coil delivery wire was found to be kinked/bent.On inspection, the main coil was found to be broken/fractured from the coil delivery wire and not returned.An assignable cause of procedural factors will be assigned to the as reported 'coil in catheter friction' as well as the as analyzed 'coil delivery wire kinked/bent' and 'main coil broken/fractured during use' as these defects appears to be 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 factors during use.

• Brand Name: TARGET 360 ULTRA 4MM X 8CM
• 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: 16721983
• Report Number: 3008881809-2023-00183
• Device Sequence Number: 7190780
• Product Code: HCG
• UDI-Device Identifier: 04546540675927
• UDI-Public: 04546540675927
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 04/12/2023

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: 09/05/2024
• Device Model Number: M0035424080
• Device Catalogue Number: M0035424080
• Device Lot Number: 23150825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2021
• 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: OPTIMA SYSTEM COILS (UNKOWN); TARGET COIL ULTRA HELICAL (STRYKER)
• Patient Sex: Male