MYNX CONTROL VENOUS

Description of Event or Problem

AS REPORTED, A PATIENT THAT RECEIVED FOUR 6F-12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICES (VCD¿S) POST SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION THERAPY FOLLOWED UP AT ANOTHER HOSPITAL POST-PROCEDURE WITH DEEP VEIN THROMBOSES (DVT'S). THE PATIENT PRESENTED WITH RIGHT SIDED CELLULITIS AND HAD TESTING SHOWING BILATERAL DVT'S. THE DEPLOYER WAS CERTIFIED AND PROFICIENT. FOUR 6F¿12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICES (VCDS) WERE USED, WITH TWO DEVICES DEPLOYED IN EACH OF THE RIGHT AND LEFT FEMORAL VEINS. VESSEL DIAMETER VERIFICATION WAS UNKNOWN BUT WAS DESCRIBED AS NORMAL PHYSICIAN PRACTICE. NO VESSEL TORTUOSITY, PERIPHERAL VASCULAR DISEASE, CALCIUM, PLAQUE, STENOSIS, OR OTHER ABNORMALITY NEAR THE ACCESS SITES WAS REPORTED. THE ACCESS SITES HAD NOT BEEN ACCESSED WITHIN THE PREVIOUS 30 DAYS, AND NO PRIOR INJURY, TRAUMA, OR ABNORMALITY NEAR THE ACCESS SITES WAS REPORTED. THE PATIENT HAS HISTORY OF INDICATED METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) POSITIVITY AND PENICILLIN/VANCOMYCIN (REDNESS & ITCHING) AND AN ADHESIVE ALLERGY. THE PATIENT RECEIVED 2 G OF ANCEF DURING THE PROCEDURE. XARELTO WAS ORDERED AFTER THE PROCEDURE BUT WAS NOT FILLED. LOCAL ANESTHESIA WAS USED, AND THE PROCEDURE WAS PERFORMED ON AN OUTPATIENT BASIS. THE DEVICES WERE STORED, PREPARED, AND USED ACCORDING TO THE INSTRUCTIONS FOR USE. THE PACKAGING WAS NOT COMPROMISED, WAS OPENED IN A STERILE FIELD, AND HOSPITAL PROTOCOLS, INCLUDING STERILE TECHNIQUE, WERE FOLLOWED. DEPLOYMENT WAS REPORTED AS NORMAL, WITH NO ISSUES IN THE LABORATORY. A CARTO SUPRAVENTRICULAR TACHYCARDIA SYSTEM WAS USED DURING THE PROCEDURE. CORDIS SHEATHS WERE USED, WITH 6F AND 7F SHEATHS ON THE RIGHT AND TWO 7F SHEATHS ON THE LEFT. NO DEPLOYMENT COMPLICATIONS WERE REPORTED, AND ALL FOUR DEVICES ACHIEVED HEMOSTASIS. THE RIGHT FEMORAL VEIN SITE WAS NOTED TO BE OOZING DURING RECOVERY AND WAS TREATED WITH QUICKCLOT AND 10 MINUTES OF MANUAL COMPRESSION. THE PATIENT LATER AMBULATED AND WAS DISCHARGED. THE PATIENT WAS STABLE, RECEIVING ANTICOAGULATION, AND SCHEDULED TO FOLLOW UP WITH THE PHYSICIAN. RIGHT-SIDED SORENESS AND CELLULITIS WERE REPORTED DURING AN EMERGENCY ROOM (ER) VISIT FOUR DAYS LATER ALONG WITH CONTINUED BLEEDING NEGATIVE PVI TESTING, AND A SMALL HEMATOMA DOCUMENTED DURING CARDIOLOGY CONSULTATION. NO CULTURE WAS OBTAINED, AND ANTIBIOTICS WERE GIVEN. SIX DAYS POST PROCEDURE, THE PATIENT WENT BACK TO THE ER. THERE WAS NO RECURRENT BLEEDING, PVL TESTING WAS NEGATIVE, A TEMPERATURE OF 103°F WAS RECORDED, AND ACUTE BILATERAL NON-OCCLUSIVE DEEP VEIN THROMBOSES (DVT) WERE REPORTED. BUT WAS NOT HOSPITALIZED AND DID NOT HAVE AN EXTENDED HOSPITALIZATION BECAUSE OF THE EVENT. TWENTY-SIX DAYS LATER, THE PATIENT WAS NO LONGER RECEIVING ANTIBIOTICS AND WAS RECEIVING AN ORAL ANTICOAGULANT. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

Additional Manufacturer Narrative

DUE TO SYSTEM LIMITATIONS, SECTION H6 REQUIRED TO INPUT TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS FOR AN INITIAL REPORT. PENDING ADDITIONAL INFORMATION TO COMPLETE INVESTIGATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.