HEMOSPRAY ENDOSCOPIC HEMOSTAT
Report
- Report Number
- 1037905-2022-00203
- Event Type
- Malfunction
- Date Received
- May 6, 2022
- Date of Event
- April 4, 2022
- Report Date
- June 10, 2022
- Manufacturer
- WILSON-COOK MEDICAL INC
- Product Code
- QAU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE PRODUCT CODE: QAU, 510K: K200972. 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. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. 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. PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.
CONTINUED: SECTION D: COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE PRODUCT CODE: QAU. SECTION G: 510K: K200972. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN BIOBAG. NO LOT INFORMATION WAS INCLUDED IN THE RETURN. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. ALL COMPONENTS WERE NOT INCLUDED IN THE RETURN (ONLY ONE CATHETER WAS RETURNED), THEREFORE A COMPLETE EVALUATION WAS NOT POSSIBLE. THE DEVICE WAS RETURNED WITH THE ON/OFF SWITCH IN THE "OFF" POSITION. THE RED ACTIVATION KNOB WAS DISENGAGED IN THE HANDLE INDICATING DEACTIVATION OF THE CARBON DIOXIDE (CO2) CARTRIDGE. POWDER WAS PRESENT INSIDE THE TUBING AND ON THE EXTERIOR OF THE CATHETER. THE POWDER INSIDE THE TUBING CONTAINED AREAS OF DISCOLORATION AND APPARENT HARD CLUMPS. THE DEVICE WAS NOT TESTED AS RETURNED DUE TO BEING PREVIOUSLY DEACTIVATED. THE CO2 CARTRIDGE WAS FULLY PUNCTURED. THE LANCE POSITION WAS MEASURED AND FOUND TO BE POSITIONED CORRECTLY. A VISUAL EXAMINATION OF THE O-RING AND LANCE INSIDE THE HANDLE SHOWED BOTH COMPONENTS TO BE POSITIONED CORRECTLY INSIDE THE HANDLE AND THE LANCE TO BE BEVELED. WHEN TESTED WITH A NEW CO2 CARTRIDGE AND ACTIVATION KNOB, THE DEVICE SPRAYED AS INTENDED. THE RETURNED CATHETER WAS ATTACHED AND DID NOT SPRAY AS INTENDED WHEN TESTED. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: THE RETURNED DEVICE WAS FUNCTIONALLY TESTED AND FOUND TO SPRAY AS INTENDED WITHOUT THE CATHETER, BUT UNABLE TO SPRAY WITH THE CATHETER ATTACHED. THE ROOT CAUSE FOR THE REPORT OF UNABLE TO SPRAY FOR THE USED DEVICE IS A CLOGGED CATHETER. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. THE CAUSE OF THE CLOGGED CATHETER IS UNKNOWN. CATHETER OCCLUSION/CLOGGING CAN BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE. TO ASSIST THE USER, THE INSTRUCTIONS FOR USE STATE THE FOLLOWING, "NOTE: DO NOT TEST DEVICE PRIOR TO INSERTION INTO ENDOSCOPE ACCESSORY CHANNEL AS THIS MAY INCREASE RISK OF CATHETER OCCLUSION." THE INSTRUCTIONS FOR USE ALSO STATES, "PRECAUTION: TO AVOID CATHETER OCCLUSION, DO NOT PLACE CATHETER DIRECTLY IN CONTACT WITH BLOOD AND/OR MUCOSA, INCLUDING ANY POOLED BLOOD AND DO NOT ASPIRATE BLOOD WHILE CATHETER IS IN ACCESSORY CHANNEL... NOTE: IF CATHETER BECOMES OCCLUDED, TURN RED VALVE TO CLOSED POSITION, REMOVE CATHETER FROM ENDOSCOPE AND REPLACE WITH EXTRA CATHETER PROVIDED IN PACKAGE." TO ASSIST THE USER IN PREPARING AND USING THE DEVICE, THE INSTRUCTIONS FOR USE STATES, "REMOVE DEVICE FROM PACKAGE AND ATTACH CATHETER TO HANDLE, ENSURING CONNECTION IS SECURE... BEFORE INSERTING CATHETER INTO ACCESSORY CHANNEL, IDENTIFY BLEEDING SITE, REMOVE AS MUCH BLOOD AS POSSIBLE, THEN FLUSH ACCESSORY CHANNEL WITH AIR... SLOWLY ADVANCE CATHETER THROUGH ACCESSORY CHANNEL IN SHORT INCREMENTS UNTIL CATHETER TIP IS VISUALIZED ENDOSCOPICALLY." PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.
DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) FOR A GASTROINTESTINAL BLEED IN THE STOMACH, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT THE HEMOSPRAY STOPPED WORKING. THE PHYSICIAN WAS ABLE TO SPRAY 2-3 TIMES FOR 2-3 SECONDS AND THEN IT STOPPED WORKING. THEY CHANGED TO THE SECOND CATHETER WHICH WORKED AT FIRST THEN STOPPED AGAIN. THE BLEEDING STOPPED SO THEY DID NOT OPEN A SECOND DEVICE. AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1089103 | HEMOSPRAY ENDOSCOPIC HEMOSTAT | QAU | WILSON-COOK MEDICAL INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | OLYMPUS SCOPE, BIOPSY CAP |