Description of Event or Problem · 0
THE FOLLOWING OCCURRED IN A PHYSICIAN-OWNED CATHETERIZATION LABORATORY. AN INTERVENTIONAL CARDIOLOGIST PERFORMED A CORONARY INTERVENTIONAL PROCEDURE ON A PATIENT, SEEMINGLY WITHOUT INCIDENT. LATE IN THE PATIENT'S RECOVERY, THE PATIENT BEGAN COMPLAINING OF PAIN IN HIS RIGHT BICEPS AREA THAT HE DESCRIBED A POKING SENSATION WHEN HE BENT AT THE ELBOW. HE WAS ASSESSED BY THE OPERATING PHYSICIAN WHO FELT THE PATIENT WAS HAVING SOME DISCOMFORT FROM THE TRANSITIONING OF CATHETERS NECESSARY IN THE CASE. THIS PATIENT WAS DISCHARGED BUT PRESENTED TO THE LOCAL EMERGENCY ROOM DURING THE OVERNIGHT HOURS WITH ONGOING SIMILAR COMPLAINTS. IMAGING DEMONSTRATED A LONG, SMOOTH-WALLED 2MM DIAMETER OBJECT IN THE FASCIA OF THE BICEPS MUSCLE WITH EVIDENCE OF A SMALL HEMATOMA. SURGERY WAS PERFORMED WITH ULTRASOUND GUIDANCE. THE VASCULAR SURGEON WAS ABLE TO EXTRACT A ROUGHLY 17CM LONG GREEN COLORED DILATOR (MINUS THE HUB OF THE DILATOR) FROM THE FASCIA SURROUNDING THE PATIENT'S RIGHT BICEPS IDENTICAL TO THE 6F MERIT MEDICAL SYSTEMS, INC. DILATOR USED TO INSERT THE SHEATH FROM THE COMPANY'S 6F TRANS-RADIAL ACCESS KIT (PRODUCT PSI-6F-11-018) FOR ACQUIRING RIGHT RADIAL ACCESS IN THE PROCEDURE. THOUGH NOT OBSERVED DURING THE PROCEDURE, IT IS MY BELIEF THAT THE DILATOR FRACTURED FROM ITS HUB WITHOUT CAUSE AFTER ADVANCING THE SHEATH INTO POSITION AND UPON WITHDRAWING BOTH THE GUIDEWIRE AND THE HUB (NON-VASCULAR SIDE) OF THE DILATOR. FURTHER HYPOTHESIZING, THE NEXT PROCEDURAL STEP OF INSERTING THE GUIDE CATHETER AND WIRE UNKNOWINGLY ADVANCED THE DILATOR (MINUS THE HUB) TO THE NORMAL ARTERIAL BEND IN THE ELBOW WHERE THE SHEATH TRACKED EXTRAVASCULAR EVEN AS THE GUIDEWIRE AND GUIDE CATHETER TRACKED NORMALLY TO COMPLETE THE CASE WITHOUT INCIDENT. SEPARATION OF A DILATOR AT THE HUB IS NOT SUPPOSED TO OCCUR, AND IN MY 30+ YEAR CAREER I'VE NOT SEEN IT BEFORE. IT'S ALSO IMPORTANT TO NOTE THERE WAS NO DIFFICULTY ACQUIRING VASCULAR ACCESS (I.E. VESSEL SPASM OR EXCESSIVE TORTUOSITY). IN THE INTERIM OF COLLECTING FACTS BUT YET NOT REPORTING, THE SAME PHYSICIAN HAD A SIMILAR OCCURRENCE OF BODY/HUB SEPARATION OF THE SAME ITEM BELIEVED TO HAVE THE SAME LOT NUMBER, THIS TIME WITHOUT PATIENT HARM. FOLLOWING THIS SECOND CASE, I COLLECTED ALL THE PRODUCT OF SAME LOT WITHIN THE FACILITY TO SEND BACK TO THE MANUFACTURER. ON EXAMINATION, ONE OF THE STERILE PACKAGES BEING RETURNED HAD CLEAR VISUAL EVIDENCE OF PARTIAL SEPARATION OF ITS DILATOR BODY FROM THE HUB OF THE DEVICE. THIS UNOPENED ITEM AND THE ITEMS FROM THIS SECOND CASE WERE PHOTOGRAPHED AND PROVIDED TO THE MERIT MEDICAL SYSTEMS, INC. SALES REPRESENTATIVE FOR COMPANY INVESTIGATION AND REPORTING ON (B)(6) 2023, NOTING OUR SUSPICIONS VERBALLY AND IN EMAIL. I ALSO ASKED THE SALES REP TO RETURN APPROXIMATELY 30 UNITS FROM OUR SHELVES THAT HAD THE SAME LOT NUMBER. FORTUNATELY, THE PATIENT HAD A SEEMINGLY UNEVENTFUL SURGERY WITH A RATHER SMALL SCAR; HE WENT HOME FROM THE HOSPITAL THE SAME DAY. REFERENCE REPORTS: MW5146977 AND MW5146978.