MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035423060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported during the procedure while re-positioning the subject coil and re-inserting it into the catheter, the device was detached from the delivery wire and stuck in the catheter.The physician used a guidewire to remove the detached coil from the catheter.The procedure was completed successfully with no clinical consequences to the patient.
Event or Problem Description
It was reported during the procedure while re-positioning the subject coil and re-inserting it into the catheter, the device was detached from the delivery wire and stuck in the catheter.The physician used a guidewire to remove the detached coil from the catheter.The procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the main coil was found to be detached/separated and kinked/bent.A functional inspection for the reported 'coil in catheter friction' could not be performed as the main coil was detached.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 device was returned and analyzed.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 main coil was found to be detached/separated and kinked/bent.An assignable cause of procedural factors will be assigned to the as reported and as analyzed '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.An assignable cause of handling damage was assigned to the as analyzed 'main coil kinked/bent' as the defect appears to be associated with handling of the product or portion of the product during the procedure.An assignable cause of 'not confirmed' will be assigned to the as reported 'coil in catheter friction ' as the coil was separated/detached from the coil delivery wire when returned and could not be confirmed.

• Brand Name: TARGET 360 ULTRA 3MM 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: 15580908
• Report Number: 3008881809-2022-00502
• Device Sequence Number: 17698417
• Product Code: HCG
• UDI-Device Identifier: 04546540675880
• UDI-Public: 04546540675880
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: 03/02/2025
• Device Model Number: M0035423060
• Device Catalogue Number: M0035423060
• Device Lot Number: 23514584
• 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: 09/21/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2022
• 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: GUIDEWIRE (UNKNOWN).; SL-10 MICROCATHETER (STRYKER).
• Patient Sex: Unknown