MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035476300
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject coil had prematurely deployed during use.There were no reported clinical consequences to the patient.No further information was provided.
Additional Manufacturer Narrative
D4: expiration date - added.H4: manufacturing date - added.H3: device evaluated by mfg summary /summary attached- updated.The device history record (dhr) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.Analysis of the return device revealed that the coil delivery wire was kinked likely due to handling.In addition, the main coil appeared to be manually detached and was not returned for analysis, thus confirming the reported event.The main coil likely prematurely detached while it was being manipulated/re-positioned during use and it is most likely that the procedural or anatomical factors encountered during the procedure contributed to the reported event.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.Based on the information available and analysis of the returned device, an assignable cause of 'procedural factors¿ will be assigned to this investigation, 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 the subject coil had prematurely deployed during use.There were no reported clinical consequences to the patient.No further information was provided.

• Brand Name: TARGET 360 SOFT 6MM X 30CM
• 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: 9521254
• Report Number: 3008881809-2019-00410
• Device Sequence Number: 11574257
• Product Code: HCG
• UDI-Device Identifier: 04546540676559
• UDI-Public: 04546540676559
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

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: 03/02/2022
• Device Model Number: M0035476300
• Device Catalogue Number: M0035476300
• Device Lot Number: 21275380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 02/05/2020
• 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: MICOCATHETER (UNKNOWN MFG)