COLON DECOMPRESSION SET
Report
- Report Number
- 3001845648-2022-00733
- Event Type
- Malfunction
- Date Received
- October 27, 2022
- Date of Event
- September 30, 2022
- Report Date
- October 24, 2024
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FEG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PMA/510(K) # K171619. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA 510K #K171619. DEVICE EVALUATION. THE CDSG-14-175 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THE PHOTOS ATTACHED TO THE FILE APPEAR TO SHOW ELONGATION OF THE WIRE GUIDE PROTRUDING FROM THE TUBE. LAB EVALUATION THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HOWEVER, PRIOR TO DISTRIBUTION ALL CDSG DEVICES ARE SUBJECT TO VISUAL A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. REVIEW OF HISTORICAL DATA: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. THE INSTRUCTIONS FOR USE, IFU0102, STATES THE FOLLOWING: VISUALLY INSPECT THE PACKAGING AND DEVICE. IF THE PACKAGING IS OPENED OR DAMAGED WHEN RECEIVED, DO NOT USE. IF A DEVICE ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE. ONCE COLON DECOMPRESSION TUBE IS ADVANCED TO TARGET AREA, UNDER PERIODIC FLUOROSCOPIC MONITORING WITHDRAW BOTH GUIDING CATHETER AND WIRE GUIDE, MAKING CERTAIN THE COLON DECOMPRESSION TUBE REMAINS STATIONARY WITHIN THE COLON. CAUTION: FAILURE TO MONITOR THE COLON DECOMPRESSION TUBE FLUOROSCOPICALLY MAY RESULT IN DISLODGEMENT OF THE COLON DECOMPRESSION TUBE. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. AS PER PRODUCT MANAGER INPUT TO MEDICAL ADVISOR, FLEXIBLE SIGMOIDOSCOPY PROCEDURE IS NOT CONSIDERED OFF LABEL USE. IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO INCLUDE THE POSITION OF THE COLONOSCOPE DURING DEVICE PLACEMENT. IT¿S POSSIBLE THAT THE IF THE COLONOSCOPE WAS IN A FLEXED POSITION DURING PLACEMENT OF THE DEVICE IT MAY HAVE CAUSED OR CONTRIBUTED TO DIFFICULTY WHEN REMOVING THE WIRE GUIDE/GUIDING CATHETER TO LEAVE THE DECOMPRESSION TUBE IN PLACE. IT¿S ALSO POSSIBLE THAT A DIFFICULT/TORTUOUS PATIENT ANATOMY MAY HAVE EXERTED EXTRINSIC FORCE ON THE DEVICE DURING PLACEMENT AND/OR REMOVAL OF THE WIRE GUIDE/GUIDING CATHETER. THIS FORCE MAY HAVE CAUSED AND/OR CONTRIBUTED TO COMPRESSION OF THE DEVICE RESULTING IN THE DECOMPRESSION TUBE BECOMING STUCK ON THE WIRE GUIDE AND/OR THE USER EXPERIENCING DIFFICULTY IN REMOVING THE WIRE GUIDE AND GUIDING CATHETER. ANOTHER POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO KINKING OF THE WIRE GUIDE OR DEVICE DURING THE DEVICE PREPARATION STAGE OR ADVANCEMENT INTO THE BODY. A KINK IN THE WIRE GUIDE MAY HAVE POSSIBLY PREVENTED THE REMOVAL OF THE DEVICE FROM THE WIRE GUIDE. SUMMARY COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO INCLUDE THE POSITION OF THE COLONOSCOPE DURING DEVICE PLACEMENT. IT¿S POSSIBLE THAT THE IF THE COLONOSCOPE WAS IN A FLEXED POSITION DURING PLACEMENT OF THE DEVICE IT MAY HAVE CAUSED OR CONTRIBUTED TO DIFFICULTY WHEN REMOVING THE WIRE GUIDE/GUIDING CATHETER TO LEAVE THE DECOMPRESSION TUBE IN PLACE. IT¿S ALSO POSSIBLE THAT A DIFFICULT/TORTUOUS PATIENT ANATOMY MAY HAVE EXERTED EXTRINSIC FORCE ON THE DEVICE DURING PLACEMENT AND/OR REMOVAL OF THE WIRE GUIDE/GUIDING CATHETER. THIS FORCE MAY HAVE CAUSED AND/OR CONTRIBUTED TO COMPRESSION OF THE DEVICE RESULTING IN THE DECOMPRESSION TUBE BECOMING STUCK ON THE WIRE GUIDE AND/OR THE USER EXPERIENCING DIFFICULTY IN REMOVING THE WIRE GUIDE AND GUIDING CATHETER. ANOTHER POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO KINKING OF THE WIRE GUIDE OR DEVICE DURING THE DEVICE PREPARATION STAGE OR ADVANCEMENT INTO THE BODY. A KINK IN THE WIRE GUIDE MAY HAVE POSSIBLY PREVENTED THE REMOVAL OF THE DEVICE FROM THE WIRE GUIDE. FAILURE IDENTIFIED: UNABLE TO REMOVE WIRE GUIDE AND GUIDING CATHETER LEAVING COLON DECOMPRESSION TUBE IN POSITION. 1 DEVICE, CONFIRMED USED. THERE WAS NO INFORMATION PROVIDED RELATED TO PATIENT OUTCOME. HOWEVER AS MEDICAL ADVISORS INPUT, MEDICAL INTERVENTION WAS REQUIRED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PMA/510(K) # K171619. SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING A REVIEW OF THIS COMPLAINT FILE. UPDATES TO INVESTIGATION FINDINGS TO BE REPORTED. DEVICE EVALUATION: THE CDSG-14-175 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THE PHOTOS ATTACHED TO THE FILE APPEAR TO SHOW ELONGATION OF THE WIRE GUIDE PROTRUDING FROM THE TUBE. LAB EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW: MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HOWEVER, PRIOR TO DISTRIBUTION ALL CDSG DEVICES ARE SUBJECT TO VISUAL A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES. REVIEW OF HISTORICAL DATA: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. THE INSTRUCTIONS FOR USE, IFU0102, STATES THE FOLLOWING: VISUALLY INSPECT THE PACKAGING AND DEVICE. IF THE PACKAGING IS OPENED OR DAMAGED WHEN RECEIVED, DO NOT USE. IF A DEVICE ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE. ONCE COLON DECOMPRESSION TUBE IS ADVANCED TO TARGET AREA, UNDER PERIODIC FLUOROSCOPIC MONITORING WITHDRAW BOTH GUIDING CATHETER AND WIRE GUIDE, MAKING CERTAIN THE COLON DECOMPRESSION TUBE REMAINS STATIONARY WITHIN THE COLON. CAUTION: FAILURE TO MONITOR THE COLON DECOMPRESSION TUBE FLUOROSCOPICALLY MAY RESULT IN DISLODGEMENT OF THE COLON DECOMPRESSION TUBE. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. AS PER PRODUCT MANAGER INPUT TO MEDICAL ADVISOR, FLEXIBLE SIGMOIDOSCOPY PROCEDURE IS NOT CONSIDERED OFF LABEL USE. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE OF THE DEVICE BEING USED IN A BEING USED IN A FLEXED POSITION BY THE PHYSICIAN CAN BE ATTRIBUTED TO THE PATIENT EXHIBITING A DIFFICULT /TORTUOUS ANATOMY WHICH MAY HAVE REQUIRED THE USER TO ALTER THE POSITION AND ADOPT A MORE FLEXED/ANGULATED POSITION WHEN ADVANCING THE GUIDING CATHETER AND THE DECOMPRESSION TUBE WHICH LED TO THE SUBSEQUENT DIFFICULTY IN REMOVING THE CATHETER. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE OF THE DEVICE BEING USED IN A BEING USED IN A FLEXED POSITION BY THE PHYSICIAN CAN BE ATTRIBUTED TO THE PATIENT EXHIBITING A DIFFICULT /TORTUOUS ANATOMY WHICH MAY HAVE REQUIRED THE USER TO ALTER THE POSITION AND ADOPT A MORE FLEXED/ANGULATED POSITION WHEN ADVANCING THE GUIDING CATHETER AND THE DECOMPRESSION TUBE WHICH LED TO THE SUBSEQUENT DIFFICULTY IN REMOVING THE CATHETER. FAILURE IDENTIFIED: UNABLE TO REMOVE WIRE GUIDE AND GUIDING CATHETER LEAVING COLON DECOMPRESSION TUBE IN POSITION. 1 DEVICE, CONFIRMED USED. THERE WAS NO INFORMATION PROVIDED RELATED TO PATIENT OUTCOME. HOWEVER AS MEDICAL ADVISORS INPUT, MEDICAL INTERVENTION WAS REQUIRED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PMA/510(K) # K171619. SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING A REVIEW OF THIS COMPLAINT FILE. CORRECTION TO THE F CODE (HEALTH EFFECTS: HEALTH IMPACT): UPDATED FROM F19 (SURGICAL INTERVENTION) TO F1905 (DEVICE REVISION OR REPLACEMENT) TO ALIGN WITH INFORMATION OUTLINED IN THE COMPLAINT AS NO SURGICAL INTERVENTION ACTUALLY OCCURRED. DEVICE EVALUATION. THE CDSG-14-175 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THE PHOTOS ATTACHED TO THE FILE APPEAR TO SHOW ELONGATION OF THE WIRE GUIDE PROTRUDING FROM THE TUBE. LAB EVALUATION. THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HOWEVER, PRIOR TO DISTRIBUTION ALL CDSG DEVICES ARE SUBJECT TO VISUAL A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES. REVIEW OF HISTORICAL DATA: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. THE INSTRUCTIONS FOR USE, IFU0102, STATES THE FOLLOWING: VISUALLY INSPECT THE PACKAGING AND DEVICE. IF THE PACKAGING IS OPENED OR DAMAGED WHEN RECEIVED, DO NOT USE. IF A DEVICE ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE. ONCE COLON DECOMPRESSION TUBE IS ADVANCED TO TARGET AREA, UNDER PERIODIC FLUOROSCOPIC MONITORING WITHDRAW BOTH GUIDING CATHETER AND WIRE GUIDE, MAKING CERTAIN THE COLON DECOMPRESSION TUBE REMAINS STATIONARY WITHIN THE COLON. CAUTION: FAILURE TO MONITOR THE COLON DECOMPRESSION TUBE FLUOROSCOPICALLY MAY RESULT IN DISLODGEMENT OF THE COLON DECOMPRESSION TUBE. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. AS PER PRODUCT MANAGER INPUT TO MEDICAL ADVISOR, FLEXIBLE SIGMOIDOSCOPY PROCEDURE IS NOT CONSIDERED OFF LABEL USE. IMAGE REVIEW. AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE OF THE DEVICE BEING USED IN A BEING USED IN A FLEXED POSITION BY THE PHYSICIAN CAN BE ATTRIBUTED TO THE PATIENT EXHIBITING A DIFFICULT /TORTUOUS ANATOMY WHICH MAY HAVE REQUIRED THE USER TO ALTER THE POSITION AND ADOPT A MORE FLEXED/ANGULATED POSITION WHEN ADVANCING THE GUIDING CATHETER AND THE DECOMPRESSION TUBE WHICH LED TO THE SUBSEQUENT DIFFICULTY IN REMOVING THE CATHETER. SUMMARY. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE OF THE DEVICE BEING USED IN A BEING USED IN A FLEXED POSITION BY THE PHYSICIAN CAN BE ATTRIBUTED TO THE PATIENT EXHIBITING A DIFFICULT /TORTUOUS ANATOMY WHICH MAY HAVE REQUIRED THE USER TO ALTER THE POSITION AND ADOPT A MORE FLEXED/ANGULATED POSITION WHEN ADVANCING THE GUIDING CATHETER AND THE DECOMPRESSION TUBE WHICH LED TO THE SUBSEQUENT DIFFICULTY IN REMOVING THE CATHETER. FAILURE IDENTIFIED: UNABLE TO REMOVE WIRE GUIDE AND GUIDING CATHETER LEAVING COLON DECOMPRESSION TUBE IN POSITION. 1 DEVICE CONFIRMED USED. THERE WAS NO INFORMATION PROVIDED RELATED TO PATIENT OUTCOME. HOWEVER AS MEDICAL ADVISORS INPUT, MEDICAL INTERVENTION WAS REQUIRED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
WE HAD ISSUES WITH PULLING THE WIRE OUT OF THE DECOMPRESSION TUBE. DECOMPRESSED WITH THE SCOPE. PATIENT HAD TO COME BACK FOR ANOTHER DECOMPRESSION THE FOLLOWING MONDAY AND WE DIDN'T HAVE A TUBE. WHAT PROCEDURE WAS BEING PERFORMED? FLEXIBLE SIGMOIDOSCOPY. WAS THE DEVICE FLUSHED BEFORE USE? YES. WHAT WAS FLUSHED THROUGH THE DEVICE? WATER. FLUSHED WITH WATER AND LUBRICANT. WAS LUBRICATION APPLIED TO THE DECOMPRESSION TUBE? YES. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? 14 FR COLON DECOMPRESSION SET. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? DECOMPRESSED WITH THE SCOPE. PATIENT HAD TO COME BACK FOR ANOTHER DECOMPRESSION THE FOLLOWING MONDAY AND WE DIDN'T HAVE A TUBE. LEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE. SIGMOID COLON. HOW EXPERIENCED WAS THE PHYSICIAN WITH USING THE CDSG? VERY EXPERIENCED. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? POSSIBLY. WHAT INTERVENTION (IF ANY) WAS REQUIRED? WE WERE ABLE TO DECOMPRESS WITH THE SCOPE. ADDED ON FOR THE FOLLOWING MONDAY TO BE DECOMPRESSED SO THE PT CAN GO TO SURGERY. WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? SAME DAY. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK) NO. WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? OLYMPUS HQ190 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DECOMPRESSION TUBE INTO POSITION? NO NOT THAT I SAW. IF RESISTANCE WAS ENCOUNTERED, WAS THE ENDOSCOPE WITHDRAWN A SHORT DISTANCE? THE SCOPE WAS NO IN THE P/T. HOW OFTEN WAS THE DECOMPRESSION TUBE IRRIGATED? IT WAS IRRIGATED/FLUSHED BEFORE THE TUBE WAS PLACED IN THE PT. DID ANY SECTION OF THE DEVICE DETACH INSIDE THE ENDOSCOPE OR PATIENT? NO. HOW LONG WAS THE SET LEFT IN DWELLING? IT WAS NOT LEFT IN LONG AT ALL. AS SOON AS IT STARTED TO FRAY, PHYSICIAN PULLED TUBE.
SUPPLEMENT REPORT BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 10-JAN-2024.
SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING A REVIEW OF THIS COMPLAINT FILE. UPDATES TO INVESTIGATION FINDINGS TO BE REPORTED.
SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING A REVIEW OF THIS COMPLAINT FILE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2761864 | COLON DECOMPRESSION SET | FEG TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION | FEG | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |