CRYOSPRAY ABLATION SYSTEM

Description of Event or Problem

A PT RECENTLY TREATED WITH THE CRYOSPRAY ABLATION SYSTEM FOR RADIATION PROCTITIS COMPLAINED OF ABDOMINAL DISCOMFORT. PT RETURNED TO THE HOSPITAL WHERE TESTING REVEALED AIR IN THE CECAL CAVITY. AN OBVIOUS PERFORATION WAS NOT IDENTIFIED, ALTHOUGH THE AREA WAS INFLAMED. SURGERY WAS PERFORMED TO REMOVE AN AREA OF THE CECUM AS THE PHYSICIAN SUSPECTED A PERFORATION. THE PT WAS HOSPITALIZED FOR FOUR DAYS.

Additional Manufacturer Narrative

THE TREATING PHYSICIAN REPORTED THAT THE CRYO-DECOMPRESSION TUBE ("CDT") WAS NOT USED DURING THE THREE COMPLETED TREATMENT CYCLES. THE CDT IS DESIGNED TO VENT LN2 GAS DURING THE PROCEDURE. BEFORE STARTING THE FOURTH AND FINAL TREATMENT SPRAY, THE PHYSICIAN INSERTED THE CDT TO ASSIST IN DECOMPRESSION FROM THE GAS. DUE TO THE PATIENT'S COMPLAINTS OF DISCOMFORT, THE FOURTH AND FINAL SPRAY WAS NOT INITIATED. THE PT DRESSED AND STATED HE FELT BETTER. PT LEFT AND THREE HOURS LATER, WENT TO THE ER COMPLAINING OF LOWER ABDOMINAL PAIN AND CRAMPING. CT SCAN WAS DONE AND SHOWED AIR OUTSIDE THE BOWEL IN THE AREA OF THE CECUM. THE PT WAS TAKEN TO SURGERY AND A PORTION OF HIS COLON NEAR THE CECUM WAS REMOVED. THE REMOVED AREA WAS SENT TO PATHOLOGY AND THE RESULTS OF THE HISTOLOGICAL EXAMINATION REVEALED NO PERFORATION. IT IS SUSPECTED THAT A MICRO-PERFORATION MAY HAVE BEEN PRESENT AND HEALED ITSELF IN THE HOURS BETWEEN THE EVENT AND THE SURGERY. PHYSICIAN INDICATED THAT THIS WAS POSSIBLE. CSA MEDICAL CONSULTED A MEDICAL EXPERT WHO SUGGESTED PRE-EXISTING CONDITIONS, SUCH AS A HERNIA OR ABNORMAL FISTULA, MAY HAVE CONTRIBUTED TO THE EVENT. THIS COULD NOT BE CONFIRMED. IT IS KNOWN THAT THE TREATING PHYSICIAN DID NOT PLACE THE DECOMPRESSION TUBE PRIOR TO CRYO-THERAPY, WHICH IS CONTRARY TO TRAINING AND LABELING.