MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035423100
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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.It was reported that the subject coil failed to detach with the inzone and prematurely detached inside the microcatheter when pulling out the delivery wire.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the rhv was opened enough to allow passage of the device through without damage, the coil was advanced slowly and gently, no torque was given when advancing the delivery wire, the tapered distal end of the introducer sheath was firmly seated in the microcatheter hub, and there was no allegation against the microcatheter (excelsior 1018) used in the procedure.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that when the physician tried to place the subject coil with the microcatheter, but when the detachment performed using detachment system, the subject coil could not be detached at the first time, so the physician tried to detach again (performed a long beep twice).When the delivery wire was pulled, the subject coil was detached inside of the microcatheter.Therefore, the physician tried to push it with the delivery wire, but the tip of the delivery wire and the subject coil got stuck in the microcatheter.The subject coil was removed together with the microcatheter to the outside of the body.The same microcatheter was used with the new coil to complete the procedure.There were no reported clinical consequences to the patient.

• Brand Name: TARGET 360 ULTRA 3MM X 10CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11668634
• Report Number: 3008881809-2021-00164
• Device Sequence Number: 3049521
• Product Code: HCG
• UDI-Device Identifier: 04546540675903
• UDI-Public: 04546540675903
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/14/2021

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: 08/10/2021
• Device Model Number: M0035423100
• Device Catalogue Number: M0035423100
• Device Lot Number: 20785236
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1