MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035423080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
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 an endovascular coil embolization procedure in a patient with internal carotid artery ica aneurysm, after inserting the subject col, the operator couldn't detach it.So withdrew the subject coil out and found subject coil delivery wire was broken.The procedure was completed successfully by replacing the subject device.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during an endovascular coil embolization procedure in a patient with internal carotid artery ica aneurysm, after inserting the subject col, the operator couldn't detach it.So withdrew the subject coil out and found subject coil delivery wire was broken.The procedure was completed successfully by replacing the subject device.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Section b1 product problem - corrected - no product problem.Section h1 type of reportable event - corrected - no malfunction.H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.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 proximal contact was noted to be broken/fractured.The coil introducer sheath was found to be intact.The main coil was found to be intact.Main coil failed/unable to detach functional test was unable to perform due to damage.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 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.The device was analyzed and the main coil was seen to be intact.It was noted in the event description that when the coil failed to detach, it was withdrawn and found that the delivery wire was broken.During analysis it was noted that only the coil proximal contact was broken/fractured therefore it is probable that the condition of the device caused the failure to detach.An assignable cause of procedural factors will be assigned to the as reported and as analyzed 'main coil failed/unable to detach' 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.An assignable cause of not confirmed will be assigned to the as reported 'coil delivery wire broken/fractured during use' as the event was not confirmed during the analysis only the coil proximal wire was broken/fractured.An assignable cause of handling damage will be assigned to the as analyzed 'coil proximal contact broken/fractured' as the issue is due to handling of the product or portion of the product 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.

• Brand Name: TARGET 360 ULTRA 3MM 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: 17015364
• Report Number: 3008881809-2023-00272
• Device Sequence Number: 7555170
• Product Code: HCG
• UDI-Device Identifier: 04546540675897
• UDI-Public: 04546540675897
• 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,Followup
• Report Date (Section B): 06/02/2023

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: 07/09/2025
• Device Model Number: M0035423080
• Device Catalogue Number: M0035423080
• Device Lot Number: 23762536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2022
• 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: ECHELON MICROCATHETER (NON STRYKER); INZONE POWER SUPPLY (STRYKER)
• Patient Sex: Unknown