MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 STANDARD 15 MM X 40 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035461540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, the physician tried to resheath and remove the subject coil from the patient¿s anatomy; however, the subject coil was stretched and broken.The physician was able to remove the broken coil using a stent retriever from the patient anatomy.Another coil was used to complete the procedure.No known patient consequences reported.
Additional Manufacturer Narrative
The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, the main coil had detached due to a break at the detachment zone and the main coil was returned attached to the stent retriever and the coil was tangled.Functional testing could not be performed due to the damage noted to the device.In case of this complaint, the device was confirmed to be in good condition prior to use and there is no indication of a user error.The main coil was advanced without difficulty and is likely to have been damage during retraction of the main coil into the micorcatheter resulting in the reported events; therefore, an assignable cause of procedural factors was assigned to the as reported issue 'main coil broken/fractured inside patient' and to the as analyzed issue 'main coil prematurely detached/separated inside patient', as the issue is associated with a product that meets stryker design and manufacture specifications and was used according to the direction for use (dfu) but due to procedural and/or anatomical factors during use, the device performance was limited.
Event or Problem Description
It was reported that during the procedure, the physician tried to resheath and remove the subject coil from the patient¿s anatomy; however, the subject coil was stretched and broken.The physician was able to remove the broken coil using a stent retriever from the patient anatomy.Another coil was used to complete the procedure.No known patient consequences reported.

• Brand Name: TARGET 360 STANDARD 15 MM X 40 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8363158
• Report Number: 3008881809-2019-00051
• Device Sequence Number: 11241480
• Product Code: HCG
• UDI-Device Identifier: 07613252192534
• UDI-Public: 07613252192534
• Combination Product (Y/N): N
• 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): 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/24/2021
• Device Catalogue Number: M0035461540
• Device Lot Number: 20676957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Initial Date Received by Manufacturer: 02/02/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention