MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035422040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device not returned.
Event or Problem Description
It was reported that during the procedure, resistance was encountered when advancing the subject coil in the microcatheter tip.Pushing and pulling of the subject coil were reported a few times and the physician was able to place the coil into the target site; however, the coil was prematurely detached without using the detachment system.The physician removed the delivery wire and a guidewire was inserted to make sure the coil was not stuck inside the microcatheter.The microcatheter was removed and the procedure was completed successfully with other products.There were no patient clinical consequences reported.
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 and functional testing could not be performed since the device was implanted in the patient.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.Additional information provided by the customer indicated that the device was prepared as per dfu and continuous flush was maintained throughout 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, a cause of undeterminable was assigned to the as reported issue.
Event or Problem Description
It was reported that during the procedure, resistance was encountered when advancing the subject coil in the microcatheter tip.Pushing and pulling of the subject coil were reported a few times and the physician was able to place the coil into the target site; however, the coil was prematurely detached without using the detachment system.The physician removed the delivery wire and a guidewire was inserted to make sure the coil was not stuck inside the microcatheter.The microcatheter was removed and the procedure was completed successfully with other products.There were no patient clinical consequences reported.

• Brand Name: TARGET 360 ULTRA 2MM X 4CM
• 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: 10597753
• Report Number: 3008881809-2020-00279
• Device Sequence Number: 19804635
• Product Code: HCG
• UDI-Device Identifier: 04546540675842
• UDI-Public: 04546540675842
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

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: 09/30/2020
• Device Model Number: M0035422040
• Device Catalogue Number: M0035422040
• Device Lot Number: 19998071
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR SL-10 MICROCATHETER (STRYKER); EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Age: 46 YR