OPTISITE ARTERIAL CANNULA

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF AN OPTI20, LEAK WAS OBSERVED FROM AREA OF CONNECTION OF CANNULA BODY AND TUBING CLAMP AFTER APPROXIMATELY 16 HOURS OF PLACEMENT. REPORTEDLY, THE LEAK ORIGINATED FROM EITHER SITE OF THE BOND BETWEEN THE TUBE AND CLAMP AREA. THE VOLUME OF BLOOD LOSS WAS REPORTED TO BE 50CC. THE DEVICE WAS USED IN ECMO, FOR CANNULATION PURPOSES. AFTER LEAK WAS NOTED, THE PATIENT HAD TO BE DECANNULATED AND THE CANNULA REPLACED. THE PATIENT IS HOSPITALIZED IN STABLE CONDITION. IT WAS REPORTED THAT THE USER HAD EXTENSIVE TRAINING/EXPERIENCE WITH THE DEVICE. PER ADDITIONAL INFORMATION RECEIVED, NO TUGGING WAS REPORTED DURING PREP/USE AND NO ABNORMALITIES WERE NOTED PRIOR TO USE OF THE DEVICE.

Additional Manufacturer Narrative

H11: ADDITIONAL MANUFACTURER NARRATIVE: PRELIMINARY DEVICE EVALUATION HAS BEEN PERFORMED, HOWEVER, THE REPORTED EVENT IS PENDING ADDITIONAL INVESTIGATION AND HISTORICAL RECORD REVIEW. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN A TIMELY MANNER ONCE THE FULL INVESTIGATION HAS BEEN COMPLETED. PER REPORTED INFORMATION RECEIVED IT WAS NOTED THAT THE SUBJECT DEVICE WAS USED FOR ECMO FOR A PERIOD OF APPROXIMATELY 16 HOURS, WHICH IS NOT PART OF THE INTENDED USE FOR THIS DEVICE. THE EDWARDS LIFESCIENCES ARTERIAL PERFUSION CANNULAE ARE INDICATED FOR ARTERIAL PERFUSION IN THE EXTRACORPOREAL CIRCUIT FOR < 6 HOURS, HENCE MAKING THE USE OF THE DEVICE IN THE REPORTED INCIDENT AN OFF-LABEL USE. PER PRELIMINARY EVALUATION OF DEVICE, CUSTOMER REPORT OF CANNULA LEAKAGE WAS CONFIRMED. DEVICE WAS RETURNED WITH VISIBLE TRACES OF BLOOD. AS RECEIVED, A KINK WAS OBSERVED ON THE CANNULA BODY AT THE WIRE-REINFORCED SECTION APPROXIMATELY 4.8" FROM THE DISTAL TIP. A LEAK TEST WAS PERFORMED ON THE CANNULA AND LEAKAGE WAS OBSERVED FROM TWO PUNCTURES BOTH MEASURING APPROXIMATELY 0.10" ON THE NON WIRE-REINFORCEMENT SECTION OF THE CANNULA BODY APPROXIMATELY 7.5" FROM DISTAL TIP. NO LEAKAGE WAS OBSERVED BETWEEN THE CONNECTOR TO CANNULA JUNCTION AND THE BARB CONNECTOR TO TUBING JUNCTION. NO OTHER VISUAL DAMAGE, CONTAMINATION, OR OTHER ABNORMALITIES WERE FOUND TO THE DEVICE. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

Additional Manufacturer Narrative

A SUPPLEMENTAL MDR IS BEING SUBMITTED DUE TO ENGINEERING EVALUATION FINDINGS. UPDATED SECTION B4 (DATE OF THIS REPORT) AND G3 (DATE RECEIVED BY MANUFACTURER). UPDATED SECTION G6 (TYPE OF REPORT AND FOLLOW-UP NUMBER FILLED OUT.) UPDATED SECTION H2 (FOLLOW-UP TYPE). UPDATE SECTION H6 CODES - COMPONENT CODE, IMPACT CODE, CLINICAL CODE, DEVICE CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: ADDITIONAL MANUFACTURER NARRATIVE: REPORTED COMPLAINT OF CANNULA LEAK WAS CONFIRMED VIA PRODUCT EVALUATION. NO CORRECTIVE/REMEDIAL ACTIONS WERE REQUIRED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED BECAUSE NO LOT NUMBER WAS PROVIDED. THE SUBJECT DEVICE WAS RETURNED FOR EVALUATION. PER THE CONTRACT MANUFACTURER IT LOOKED LIKE SOMETHING SHARP MADE A CUT ALONG THE WIRE WOUND SECTION AND PUNCTURED A HOLE. AT THE OTHER LEAK SITE, IT APPEARED LIKE THE CANNULA WAS PUNCTURED BY A NEEDLE-LIKE OBJECT. IT WAS UNABLE TO BE DETERMINED HOW THE DAMAGE OCCURRED, BUT IT WAS NOT BELIEVED TO BE MANUFACTURING RELATED AND WAS NOT ABLE TO BE RECREATED. IT IS UNLIKELY THAT THE REPORTED LEAK WAS THE RESULT OF A SUPPLIER MANUFACTURING NONCONFORMANCE. THE CANNULA BODY WAS OBSERVED TO BE PUNCTURED AT TWO DIFFERENT POINTS AND A KINK WAS OBSERVED AT THE WIRE-REINFORCED SECTION. MANUFACTURING MITIGATIONS IN PLACE BY THE SUPPLIER CHECKS FOR LEAKS, DAMAGES AND KINKS DURING INSPECTION, AND IT IS UNLIKELY THAT THE OBSERVED DAMAGE IN THE RETURNED DEVICE WOULD HAVE PASSED THE INSPECTIONS DURING MANUFACTURING. SUPPLIER PERFORMED ADDITIONAL TESTING BUT WAS UNABLE TO RECREATE THE REPORTED DAMAGE. ADDITIONALLY, PER THE INSTRUCTIONS FOR USE (IFU), THE DEVICE IS INTENDED FOR SHORT-TERM USE ONLY (< 6 HOURS); HOWEVER, THE SUBJECT DEVICE WAS USED FOR APPROXIMATELY 16 HOURS FOR ECMO, WHICH IS CONSIDERED AN OFF-LABEL USE OF THE SUBJECT DEVICE. IT IS LIKELY THAT THE REPORTED LEAKAGE WAS CAUSED DUE TO INADVERTENT PUNCTURE OF THE CANNULA BODY WITH A SHARP OBJECT DURING USE. THE KINK OBSERVED MAY HAVE BEEN CAUSED DURING HANDLING AND/OR USE OF THE DEVICE AND IS UNLIKELY TO HAVE ORIGINATED FROM MANUFACTURING. BASED ON THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE OF THE REPORTED INCIDENT IS OPERATIONAL FACTORS INCLUDING INADVERTENT PUNCTURE OF THE DEVICE AND USE RELATED ERROR (OFF-LABEL USE). AN EDWARDS/SUPPLIER MANUFACTURING DEFECT HAS NOT BEEN CONFIRMED. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.