ONO RETRIEVAL DEVICE

Additional Manufacturer Narrative

THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING OF THE LOT. IN PROCESS TENSILE TESTING AT THE BASKET TO SHAFT BOND EXCEEDED THE DESIGN SPECIFICATION OF 17.5 LBF FOR ALL SAMPLES. DEVICES FROM THE SAME LOT WERE INSPECTED AND TENSILE TESTED, NO OBSERVATIONS WERE NOTED AND ALL SAMPLES EXCEEDED THE TENSILE STRENGTH SPECIFICATION. THE FAILURE HAS BEEN UNABLE TO BE REPLICATED.

Description of Event or Problem

A PATIENT HAD AN EMBOLIZED BSC WATCHMAN (LEFT ATRIAL APPENDAGE OCCLUDER) DEVICE AND THE ONO RETRIEVAL DEVICE WAS DEPLOYED TO RETRIEVE AND REMOVE IT. THE ONO BASKET BROKE OFF FORM THE TIP OF THE ONO CATHETER. THE ONO BASKET WAS SNARED AND REMOVED WITHOUT INJURY TO THE PATIENT THROUGH THE SHEATH. MULTIPLE ATTEMPTS TO DISCUSS WITH THE PHYSICIAN HAVE BEEN UNANSWERED.