COLON DECOMPRESSION SET

Report

Report Number: 3001845648-2018-00078
Event Type: Injury
Date Received: February 23, 2018
Date of Event: January 27, 2018
Report Date: May 17, 2018
Manufacturer: COOK IRELAND LTD
Product Code: FEG
UDI-DI: 00827002221819
PMA / PMN Number: K900035
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

Additional Manufacturer Narrative · 0

COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: ED SUTKOWSKI, COOK MEDICAL INCORPORATED (CMI), 1025 ACUFF ROAD, P.O BOX 4195, BLOOMINGTON , INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113.

Additional Manufacturer Narrative · 0

COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

Additional Manufacturer Narrative · 0

COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031 INFORMATION AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4) PROBLEM STATEMENT: THE CUSTOMER REPORTED THE FOLLOWING COMPLAINT ISSUE "DURING PULLOUT, THERE IS SHEANING OF INNERLINE." ADDITIONAL INFORMATION 22 FEB 2018; WHEN YOU STATE THE INNER LINE SHEARED WHAT YOU ARE REFERRING TO? THE DEVICE OR PATIENT ANATOMY? ¿THE SHEARING WAS ON THE DEVICE WHILE PULLING OUT THE GUIDE WIRE. THE INNER LINING OF THE DEVICE GOT SHEARED, NOT THE PATIENT'S COLON.¿ ADDITIONAL INFORMATION 06 APRIL 2018; "THE INNER LINING OF THE DECOMPRESSION TUBE WAS SHEARED. THE OUTSIDE COVERING WAS INTACT. THE SHEARED INNER LINING CAME OUTSIDE WHEN THE GUIDE WIRE WAS PULLED OUT. PT EXPIRED AFTER 1 WEEK, INTENT OF THERAPY WAS ONLY PALLIATIVE." MULTIPLE ATTEMPTS WERE MADE FOR THE FOLLOWING INFORMATION; WHAT SCOPE WAS USED WITH THIS DEVICE? WHAT WIRE GUIDE WAS USED? THE WIRE GUIDE RETURNED WITH THE DEVICE APPEARS UNUSED. WAS THE DEVICE FLUSHED PRIOR TO USE? HOWEVER, AS OF 16 APRIL 2018, THERE HAS BEEN NO REPLY. THIS COMPLAINT WILL BE UPDATED IF THIS INFORMATION IS RECEIVED. LAB EVALUATION: 1 X CDSG-14-175 DEVICE OF LOT #: (B)(4) WAS RETURNED TO CIRL FOR EVALUATION. A LAB EVALUATION WAS HELD ON 22 MARCH 2018 UPON EVALUATION OF THE RETURNED DEVICE, THE BLACK INNER CATHETER WAS BROKEN APPROX. 22CM FROM THE PROXIMAL END. THERE WAS ALSO CRUMPLING OF THE BLACK INNER CATHETER NEAR THE HUB. THE BLACK INNER CATHETER WAS ALSO NECKED IN VARIOUS LOCATIONS AND WAS PINCHED AT THE DISTAL END (LIKELY HAPPENED AFTER PROCEDURE). NO OTHER DEFECTS OBSERVED. ALTHOUGH NOT REFERENCED IN LAB NOTES, THE WIRE GUIDE THAT WAS RETURNED APPEARS UNUSED. ALSO THERE WAS SHEARING OF THE BLACK INNER CATHETER. THERE ARE A NUMBER OF USER ERRORS WHICH MAY HAVE BEEN THE CAUSE FOR THIS FAILURE, SUCH AS USING AN INAPPROPRIATELY SIZED WIRE GUIDE, NOT LUBRICATING THE DEVICE PRIOR TO USE OR NOT FOLLOWING INSTRUCTIONS (WITHDRAWING WIRE GUIDE PRIOR TO WITHDRAWING THE GUIDING CATHETER). HOWEVER, BASED ON THE LIMITED INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE USER ERROR UNLESS FURTHER INFORMATION IS PROVIDED. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED AS THE EXACT OPERATIONAL CONDITIONS OF USE COULD NOT BE REPLICATED IN THE LABORATORY SETTING. HOWEVER IT IS POSSIBLE THAT THERE WAS INSUFFICIENT CLEARANCE BETWEEN COLON DECOMPRESSION TUBE AND THE GUIDING CATHETER. IFU REVIEW: IT MAY BE NOTED THAT ACCORDING TO THE INSTRUCTIONS FOR USE, THE USER IS INSTRUCTED TO: ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF ANY ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE¿. AS PER THE NOTES SECTION OF THE IFU; "SET INCLUDES A DRAINAGE CATHETER, GUIDING CATHETER AND A .035 INCH WIRE GUIDE." AS PER THE INSTRUCTIONS FOR USE SECTION OF THE IFU: STEP 3; "INSERT .035 INCH WIRE GUIDE INTO BIOPSY CHANNEL OF COLONOSCOPE UNTIL EXITS TIP." STEP 6; "FLUSH COLON DECOMPRESSION TUBE AND 6FR GUIDING CATHETER WITH STERILE WATER OR LUBRICATE WITH WATER- SOLUBLE LUBRICANT, THEN REASSEMBLE AND ADVANCE INTO COLON OVER PRE- POSITIONED WIRE GUIDE. USE FLURORSCOPIC CONTROL TO AVOID MIGRATION OF WIRE GUIDE." ALSO, THE LABEL FOR THIS DEVICE INDICATES THAT THIS IS SUITABLE FOR A SCOPE WITH A WORKING CHANNEL OF 2.8MM. FQC/ PRD REVIEW: PRIOR TO DISTRIBUTION, ALL USI DEVICES ARE SUBJECTED TO 100% INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. AS PER THE FINISHED PRODUCT QC INSTRUCTIONS, THE MTM IS INSTRUCTED TO ¿INSPECT FOR VISUAL DEFECTS, DEBRIS IN OR ON PRODUCT, KINKS, BENDS AND SMOOTHNESS OF TIP.¿ STEP 10; "VERIFY WIRE GUIDE SIZE BEFORE EACH USE." THERE IS ALSO A VISUAL INSPECTION OF THE PRODUCT AND PACKAGING AT PACKAGING, PACKAGING QC, AND POST STERILE QC. DOCUMENT REVIEW: A REVIEW OF THE MANUFACTURING RECORDS FOR THE CDSG DEVICE OF LOT: (B)(4) DID NOT REVEAL ANY DISCREPANCY RELATED TO THE COMPLAINT ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT #: (B)(4); UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT #: (B)(4). SUMMARY: THIS COMPLAINT IS CONFIRMED AS THE DEVICE WAS FOUND TO BE DAMAGED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

Additional Manufacturer Narrative · 0

COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO MFR SITE AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(6). (B)(4). FOLLOW UP REPORT IS BEING SENT TO UPDATE THE INVESTIGATION WITH ADDITIONAL INFORMATION RECEIVED: THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON THE 11TH JUNE 2018: "DEATH IS NOT DUE TO DEVICE. IT¿S BECAUSE OF PROGNOSIS DISEASE. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO MFR SITE AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(6). (B)(4). FOLLOW UP REPORT IS BEING SENT TO UPDATE THE INVESTIGATION WITH ADDITIONAL INFORMATION RECEIVED: THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON THE 11TH JUNE 2018: "DEATH IS NOT DUE TO DEVICE. IT¿S BECAUSE OF PROGNOSIS DISEASE.