MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 STANDARD 6MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035466300
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during coil embolization procedure, the subject coil dropped by itself.Embolization procedure was continued by the physician.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No further information is available.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
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: the coil delivery wire was seen to be kinked.The coil was seen to be detached from the coil delivery wire.The main coil or the introducer sheath were not returned.Functional inspection: 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 complaint was 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 detached from the delivery wire and the returned delivery wire was found to be kinked/bent.An assignable cause of procedural factors will be assigned to the as reported/as analyzed (ar/aa) 'main coil prematurely detached/separated during use' since this issue appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.An assignable cause of handling damage will be assigned to the as analyzed (aa) 'coil delivery wire kinked/bent' since this issue is associated with handling of the device during the clinical procedure, upon removal of the device from the packaging, or preparation of the device.
Event or Problem Description
It was reported that during coil embolization procedure, the subject coil dropped by itself.Embolization procedure was continued by the physician.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No further information is available.

• Brand Name: TARGET 360 STANDARD 6MM X 30CM
• 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: 13049718
• Report Number: 3008881809-2021-00536
• Device Sequence Number: 11738011
• Product Code: HCG
• UDI-Device Identifier: 07613252239444
• UDI-Public: 07613252239444
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/11/2022

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: 09/13/2024
• Device Model Number: M0035466300
• Device Catalogue Number: M0035466300
• Device Lot Number: 23113498
• 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: 12/10/2021
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 03/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2021
• 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 Sex: Unknown