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

Model Number	M0036153060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure that the subject coil was framed within the aneurysm.Physician proceeded the with detachment processes and noted a long beep on the detachment device.Subject coil was not detached and was attempted to insert again.Friction was felt upon reinsertion and was noted to be prematurely detached upon pulling subject coil back.Subject coil was then pushed with another wire into the aneurysm and was placed near the bifurcation of the posterior communicating artery.Blood vessels were preserved by confirmation of 3d-dsa.The procedure was completed successfully and no known clinical consequences were reported to the patient due to this event.No further information is currently available.
Event or Problem Description
It was reported that during the procedure that the subject coil was framed within the aneurysm.Physician proceeded the with detachment processes and noted a long beep on the detachment device.Subject coil was not detached and was attempted to insert again.Friction was felt upon reinsertion and was noted to be prematurely detached upon pulling subject coil back.Subject coil was then pushed with another wire into the aneurysm and was placed near the bifurcation of the posterior communicating artery.Blood vessels were preserved by confirmation of 3d-dsa.The procedure was completed successfully and no known clinical consequences were reported to the patient due to this event.No further information is currently available.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as physical analysis cannot 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.Additional information provided by the customer indicated that no anomalies noted to the device prior to use.Also, preparation/set-up performed as per the directions for use and continuous flush was maintained for the duration of the procedure.And, it is most likely that anatomical or procedural factors resulted the coil detached when trying to remove.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, a cause of undeterminable will be assigned to the reported complaint.

• Brand Name: TARGET 3D 3MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 10022714
• Report Number: 3008881809-2020-00131
• Device Sequence Number: 2502602
• Product Code: HCG
• UDI-Device Identifier: 07613327004823
• UDI-Public: 07613327004823
• Combination Product (Y/N): N
• 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): 06/09/2020

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: 08/04/2022
• Device Model Number: M0036153060
• Device Catalogue Number: M0036153060
• Device Lot Number: 21621428
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 05/04/2020
• Supplement Report FDA Received Date: 06/09/2020
• 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: INZONE (STRYKER)