MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 16MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036121650
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that the subject coil predeployed in the catheter.No clinical consequences reported to the patient.
Event or Problem Description
It was reported that the subject coil redeployed in the catheter.No clinical consequences reported to the patient.
Additional Manufacturer Narrative
The edhr (electronic device history record) for the device lot is created and maintained in mes (manufacturing execution system).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.Per the additional information "coil was initially chosen to be first coil to be placed but after putting it in aneurysm, the physician noticed it was undersized and pulled it back into the catheter.When it was pulled back into the catheter it deployed inside the catheter.No nzone or electrolytic deployment was used, it detached on its own inside the catheter".It is probable that the coil was prematurely detached inside the microcatheter during the attempt to pull the coil back into the microcatheter after the initial placement inside the aneurysm.An assignable cause of procedural factors will be assigned to the reported main coil prematurely detached inside patient, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the device directions for use (dfu) but due to procedural and/or anatomical factors during use, the product performance was limited.

• Brand Name: TARGET XL 360 SOFT 16MM X 50CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8438485
• Report Number: 3008881809-2019-00075
• Device Sequence Number: 2241723
• Product Code: HCG
• UDI-Device Identifier: 04546540711557
• UDI-Public: 04546540711557
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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): 05/16/2019

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: 10/31/2020
• Device Catalogue Number: M0036121650
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 05/16/2019
• 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: CATHETER (UNKNOWN MANUFACTURER)