MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035422060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
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.Visual/microscopic inspection confirmed that the main coil was intact.The coil delivery wire was seen to be kinked/bent.The coil delivery wire was seen to be broken/fractured.The coil introducer sheath was intact.Functional inspection was not required.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 failed/unable to detach could not be confirmed; 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.The device was returned for analysis.The main coil was intact, the coil delivery wire was seen to be kinked/bent, the coil delivery wire was seen to be broken/fractured.The coil introducer sheath was intact.An assignable cause of procedural factors will be assigned to the reported main coil failed/unable to detach and as analyzed (aa) coil delivery wire broken/fractured during use, as these defects appear 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.An assignable cause of handling damage will be assigned to aa code 'coil delivery wire kinked/bent', as this defect appears to be associated with handling of the product or portion of the product during the procedure.
Event or Problem Description
The subject device was returned for analysis and the device investigation revealed that the coil delivery wire was broken/fractured during use.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 ULTRA 2MM X 6CM
• 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: 15964288
• Report Number: 3008881809-2022-00619
• Device Sequence Number: 14687097
• Product Code: HCG
• UDI-Device Identifier: 07613252239345
• UDI-Public: 07613252239345
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 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: 05/04/2024
• Device Model Number: M0035422060
• Device Catalogue Number: M0035422060
• Device Lot Number: 22893086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Race: Asian