HEMOSPRAY ENDOSCOPIC HEMOSTAT

Description of Event or Problem

DURING AN ENDOSCOPIC HEMOSTASIS PROCEDURE IN THE DUODENUM TO TREAT A COLONIC DIVERTICULAR BLEEDING, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT HEMOSPRAY WAS APPLIED FROM THE ASCENDING COLON TO THE TRANSVERSE COLON. DURING USE, THE PATIENT¿S CONDITION DETERIORATED, AND THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL. SUBSEQUENTLY, A REPORT FROM (B)(6) HOSPITAL INDICATED THAT THERE WAS AN APPROXIMATELY 20 CM TEAR IN THE TRANSVERSE COLON. AN INTESTINAL WALL PERFORATION POTENTIALLY ASSOCIATED WITH THE USE OF HEMOSPRAY WAS SUSPECTED. ADDITIONAL INFORMATION RECEIVED THE PHYSICIAN STATED THAT HE WAS CONTROLLING THE PATIENT'S CONDITION BY SUCTIONING AS NEEDED, EVEN WHILE USING HEMOSPRAY. FOLLOWING EMERGENCY TRANSFER, SURGERY WAS PERFORMED IMMEDIATELY. DURING THE PROCEDURE ON THE SAME DAY, IT WAS CONFIRMED THAT APPROXIMATELY 20 CM OF THE TRANSVERSE COLON WAS TORN. THE AFFECTED SEGMENT OF THE COLON WAS RESECTED, AND A COLOSTOMY WAS CREATED. THE PATIENT¿S CONDITION IMPROVED. PER THE PHYSICIAN, ALTHOUGH FACTORS SUCH AS THE PATIENT¿S AGE AND DAMAGE AT THE BLEEDING SITE MAY HAVE CONTRIBUTED, THE COLON HAS A RELATIVELY THIN WALL; THEREFORE, INCREASED INTRALUMINAL PRESSURE DUE TO CO2 INSUFFLATION MAY HAVE BEEN A CONTRIBUTING FACTOR. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. HEMOSTASIS WAS ACHIEVED USING AN ALTERNATE MODALITY. AN INCREASE IN INTRALUMINAL PRESSURE IN THE COLON, IMPAIRED BLOOD FLOW, AND ABDOMINAL DISTENSION WERE CONSIDERED TO HAVE LED TO COMPARTMENT SYNDROME. THE PATIENT DEVELOPED MILD RESPIRATORY IMPAIRMENT AND WAS TRANSFERRED TO THE (B)(6) HOSPITAL. A COLOSTOMY WAS CREATED, AND THE PATIENT¿S CONDITION IMPROVED.

Additional Manufacturer Narrative

CONTINUED E1 PHONE NUMBER: (B)(6). INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE IFU INCLUDES THE FOLLOWING INFORMATION RELATED TO THE OCCURRENCE OF PERFORATION: [HEMOSPRAY IS] "ALSO CONTRAINDICATED IN PATIENTS WHO HAVE GASTROINTESTINAL FISTULAS, ARE SUSPECTED OF HAVING A GASTROINTESTINAL PERFORATION, OR ARE AT HIGH RISK OF GASTROINTESTINAL PERFORATION DURING ENDOSCOPIC TREATMENT." THE IFU INDICATES THE FOLLOWING POTENTIAL COMPLICATIONS: "THOSE ASSOCIATED WITH GASTROINTESTINAL ENDOSCOPY INCLUDING: ALLERGIC REACTION TO MEDICATION, ASPIRATION, CARDIAC ARRYTHMIA OR ARREST, FEVER, HEMORRHAGE, HYPOTENSION, INFECTION, PERFORATION, RESPIRATORY DEPRESSION OR ARREST." PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.