Description of Event or Problem · 1
HEART CATHETERIZATION THROUGH RIGHT GROIN. PAIN UPON DEPLOYMENT OF DEVICE. PAIN IN RIGHT GROIN AREA AND UPPER RIGHT LEG DURING RECOVERY BEFORE BEING RELEASED FROM HOSP, AND AT HOME. BECAME EXCRUCIATING PAIN. TWO DAYS LATER, WENT TO EMERGENCY ROOM BECAUSE OF PAIN. DOCTOR UNFAMILIAR WITH PRODUCT. REQUESTED ULTRASOUND. MY HUSBAND WENT INTO THE HOSP FOR CARDIAC CATHETERIZATION/ANGIOGRAPH. WHILE RECOVERING IN HIS ROOM HE WAS HAVING PAIN IN THE GROIN OF THE RIGHT SIDE AND IN THE UPPER PART OF HIS RIGHT LEG ABOVE THE KNEE. HE BROUGHT IT TO THE ATTENTION OF HIS NURSE, SHE SAID IT MAY BE THE SOLUTION THAT WAS PUT ON THE LEG WHEN PREPPING FOR THE PROCEDURE. THIS IS THE LEG THEY WENT IN WITH THE CATHETER TO DO THE PROCEDURE. ON THE NEXT DAY STILL HAD THE PAIN AND DISCOMFORT BUT WENT HOME THINKING THIS WOULD SUBSIDE RATHER QUICKLY. UNFORTUNATELY IT WAS GETTING PROGRESSIVELY WORSE. THE PAIN AND DISCOMFORT PROGRESSED TO BECOME EXTREME PAIN, BURNING AND UNUSUAL SENSATIONS. HE WAS NOT ABLE TO WALK WITHOUT BEING IN EXCRUCIATING PAIN AND AT TIMES FELT AS THOUGHT HE WOULD PASS OUT/FAINT. HE NEEDED A CANE TO MOVE AROUND. EVERY STEP HE TOOK SHOWED ON HIS FACE HOW MUCH PAIN HE WAS IN, (WHITE AS A SHEET). HE HAD TO BE EVER SO CAREFUL HOW HE COULD MAKE ANY KIND OF MOVEMENT, EVEN WHILE SITTING, STANDING OR LAYING DOWN, BECAUSE OF TRIGGERING THE PAIN AND ODD FEELINGS HE WAS GETTING TO ITS MAX. THERE WAS PULLING, TIGHTENING, BURNING, AND SHARP PAINS. IT WAS VERY DIFFICULT TO GET COMFORTABLE. THERE WAS SWELLING AND HARDNESS IN THE AREA OF THE INCISION THAT WAS DIFFERENT THAN THE USUAL AS WELL. THIS WAS THE SEVENTH PROCEDURE OF THIS KIND FOR HIM SO HE IS WELL AWARE OF WHAT HAPPENED FROM START TO FINISH. NOTHING LIKE THIS HAS EVER HAPPENED. THIS IS ALSO THE FIRST TIME HE HAD ANY KIND OF FOREIGN OBJECT USED TO CLOSE UP THE ARTERY WHICH IS "THE STAR CLOSE VASCULAR CLOSURE SYSTEM, A NITIONOL CLIP" BY ABBOTT LABORATORES. THE CONCLSUION HAS BEEN DRAWN THAT A NERVE HAS BEEN CAUGHT BY THIS CLIP, WHICH IS CAUSING THE PAIN. THE NEXT DAY (SATURDAY) MY HUSBAND WENT TO THE EMERGENCY ROOM BECAUSE HE WAS IN A LOT OF PAIN. HE EXPLAINED WHAT HAPPENED WITHIN THE LAST COUPLE DAYS AND THIS NEW TYPE OF CLOSURE THAT WAS USED, BUT THE DR WAS UNFAMILIAR WITH IT, BEING SUCH A NEW DEVICE HE WAS NOT ABLE TO ANSWER OUR QUESTIONS TO HELP, EXCEPT TO TAKE AN ULTRASOUND AND PRESCRIBE PAIN MEDICATION. THE GROIN AREA WAS VERY SENSITIVE. THE ULTRASOUND DID NOT SHOW ANYTHING THAT COULD DETECT THE PROBLEM, AN EMERGENCY ROOM DR HAD CONTACTED HIS DR'S OFFICE AND SPOKE WITH ANOTHER DR THAT WAS COVERING FROM HIM. MY HUSBAND WAS TOLD TO CONTACT HIS CARDIOLOGIST MONDAY, NO ONE WAS FAMILIAR WITH THIS ISSUE AT HAND. ALL THEY COULD DO WAS PRESCRIBE A SMALL PORTION STRONG PAIN MEDICATION, WHICH WAS MORPHINE. HE CALLED THE CARDIOLOGIST OFFICE MONDAY, WAS CALLED THE FOLLOWING DAY AND WENT TO HIS OFFICE AT THE END OF THE DAY TO DISCUSS THE PROBLEM. DR WAS UNSURE WHAT COULD BE DONE AND THIS BEING A NEW DEVICE HE USED. WHILE WE WERE IN HIS OFFICE HE CALLED ABBOTT LABORATORES AND TOLD SOMEONE OF THE SITUATION. THE DR WANTED TO PUT THEM ON SPEAKER PHONE BUT THEY DIDN'T WANT TO DO THAT. THEY SAID THAT THERE HAS BEEN ONLY A COUPLE OF CASES THAT WERE SIMILAR, AND IT WILL TAKE 30 DAYS TO GET BETTER. THIS WAS DISHEARTENING. THE DR PRESCRIBED MORE MORPHINE TO EASE THE PAIN. THIS IS NOW JUST A WAITING GAME THAT IS NOT GOOD, WITH SOME ONE IN A LOT OF PAIN AND CAN'T GET AROUND. IT'S HARD TO TELL IF HE SHOULD BE IN THE HOSP INSTEAD OF GOING HOME. THIS IS A RIDICULOUS SITUATION TO BE IN. NO ONE SHOULD HAVE TO ENDURE THIS KIND OF PAIN FOR THIS LONG, LET ALONE 30 MORE DAYS. IN TABLES FROM STARCLOSE THEY ARE SHOWING THE RESULTS FOR THE DISCHARGE OF PTS IN A SHORTER PERIOD OF TIME THAN THE STANDARD COMPRESSION TIME. WE ARE MORE INTERESTED IN THE OVERALL SAFETY, WELLNESS AND THE LEAST AMOUNT OF DISCOMFORT THAT ONE SHOULD ENDURE. MY HUSBAND WAS NEVER TOLD THAT THIS MIGHT HAPPEN, HE WOULD HAVE CHOSEN THE WAY IT WAS DONE PRIOR, WITH NO PROBLEM OR UNBELIEVABLE PAIN THAT HE'S HAD TO PUT UP WITH. IN TALKING WITH THE DR HE WASN'T AWARE OF THESE ISSUES EITHER. HE IS STILL LIVING WITH MUCH DISCOMFORT THAT HAS BECOME A HINDRANCE FOR HIM TO DEAL WITH ON A DAILY BASIS AND NOT ABLE TO PERFORM ANY OF HIS NORMAL DAILY TASKS WITHOUT GRABBING THE GROIN/LEG AREA AND GETTING PAIN, BURNING, PULLING ETC. IN THAT AREA. THIS HAS CAUSED A LOT OF STRESS, ANXIETY AND UPSET UNNECSSARILY. WE WOULD LIKE TO KNOW WHAT IS GOING TO BE IN HIS FUTURE. IS THIS GOING TO BE A PROBLEM FOR THE REST OF HIS LIFE AND IS THIS SOMETHING THAT MAY HAVE TO BE TAKEN CARE OF AT SOME POINT IN HIS LIFE? WE UNDERSTAND AN OPERATION TO REMOVE THIS CLIP IS NOT RECOMMENED. WE WOULD LIKE TO KNOW WHAT IS ACTUALLY KNOWN ABOUT THIS STAR CLOSE CLIP, AND WHAT DOES SOMEONE DO WHEN YOU ARE READY TO HAVE THIS TAKEN OUT AS HE WAS IN FEBRUARY, WHEN YOU CAN'T DEAL WITH THE PAIN ANY MORE. FORTUNATELY TODAY HE'S NOT IN THE SAME KIND OF SEVERE AND EXTREME PAIN, BUT IS NOT TO SAY HE DOESN'T HAVE THE SAME THOUGHTS AS WHAT TO DO ABOUT THIS, AND SINCE THERE IS STILL SO MUCH DISCOMFORT ON A DAILY BASIS. WE FIND A BIG ISSUE WITH THIS CO USING DEVICES AND DOING THESE PROCEDURES NOT KNOWING HOW TO REMEDY PROBLEMS THAT MAY ARISE. ESPECIALLY WHEN IT MEANS SOMEONE CAN BE IN A LOT OF PAIN FOR A GOOD DEAL OF TIME, AND PERHAPS HAVE TO GO IN AND REMOVE IT IS MORE THAN ONE SHOULD HAVE TO GO THROUGH OR EVEN THINK ABOUT HAVING DONE, SEEMS THAT THIS IS NOT A WELL THOUGHT OUT IDEA WITH THE INTEREST OF A PT FIRST IN MIND. IF THIS WOULD HAVE TO BE REMOVED ARE THEY REALIZING JUST WHAT HAS TO BE DONE AND THE REHABILIATION AND RECOVERY TIME. HE IS REMINDED ON A DAILY BASIS THAT THIS HAS NOT CLEARED UP, FOR IT IS A PERSISTENT AND NAGGING PAIN, BURNING, PULLING ETC.