MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035476100
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
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 the procedure the coil (subject device) detached prematurely inside the micro catheter.The physician replaced it with a new device and continued the procedure without 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.The device was received.A retriever device and a catheter were included in the return packaging.The reported lot number was confirmed from the packaging label.During the initial inspection, reported event was confirmed.Analysis could not be completed as main coil fell on floor.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 during the procedure, the subject coil prematurely detached inside the microcatheter.The device was returned and the main coil had been detached from the delivery wire it is probable that the main coil was detached within the microcatheter due to procedural or anatomical factors during use.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 issue is 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.
Event or Problem Description
It was reported that during the procedure the coil (subject device)detached prematurely inside the micro catheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET 360 SOFT 6MM 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: 12178166
• Report Number: 3008881809-2021-00302
• Device Sequence Number: 16365677
• Product Code: HCG
• UDI-Device Identifier: 04546540676528
• UDI-Public: 04546540676528
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/16/2021

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: 08/06/2023
• Device Model Number: M0035476100
• Device Catalogue Number: M0035476100
• Device Lot Number: 22352194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 09/16/2021
• 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: MICROCATHETER (UNKNOWN)