UNKNOWN
Report
- Report Number
- 3001845648-2022-00412
- Event Type
- Injury
- Date Received
- July 8, 2022
- Date of Event
- March 8, 2005
- Report Date
- August 11, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K851962
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HU
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS IN PROGRESS AND A FOLLOW UP MDR WILL BE SUBMITTED.
DEVICE EVALUATION: THE 9 X DEVICES OF UNKNOWN RPN AND LOT NUMBER INVOLVED IN THIS COMPLAINT WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE TO CAPTURE ¿DRAIN CLOGGING + ACUTE CHOLANGITIS¿. ADDITIONAL COMPLAINT FILE (B)(4) (REPOT REFERENCE NUMBER 3001845648-2022-00413) WAS OPENED AS A RESULT OF THIS PAPER TO CAPTURE 5 CASES OF ¿STENT DISLOCATION¿. LAB EVALUATION: THE DEVICE LAB EVALUATION COULD NOT BE COMPLETED AS THE DEVICE, OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE, WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW : PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HISTORICAL DATA REVIEW : HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. IFU & LABEL REVIEW : AS PER IFU0045 CHOLANGITIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH AN ERCP PROCEDURE: ¿THOSE ASSOCIATED WITH ERCP INCLUDE, BUT ARE NOT LIMITED TO: PANCREATITIS, CHOLANGITIS, ASPIRATION, PERFORATION, HAEMORRHAGE, INFECTION, SEPSIS, ALLERGIC REACTION TO CONTRAST OR MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST.¿ AS PER TECHNICAL CONTENT FORM FOR PLASTIC BILIARY STENTS, STENT OCCLUSION (DRAIN CLOGGING) IS A LISTED KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH BILIARY STENT PLACEMENT. IT SHOULD BE NOTED THAT AS PER THE IFU IT STATES IN THE PRECAUTIONS SECTION ¿THIS DEVICE SHOULD NOT BE LEFT INDWELLING FOR MORE THAN THREE MONTHS OR AS DIRECTED BY A PHYSICIAN. PERIODIC EVALUATION IS RECOMMENDED.¿ AS PER THE MEDICAL ADVISOR, THE STENTS WERE ASSOCIATED WITH USER ERROR AS THEY WERE NOT REPLACED AT THE THREE-MONTH INTERVALS STATED IN THE IFU. THE PREVIOUS STENT WAS STILL IN PLACE AND WAS NOT EXCHANGED DURING THE SEQUENTIAL INSERTION OF ANOTHER STENT. WITH THE ABOVE INFORMATION, THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF USER ERROR WAS DETERMINED FROM THE AVAILABLE INFORMATION. FROM THE JOURNAL ARTICLE AND CLINICAL INPUT, IT WAS CONFIRMED THAT THE STENTS WERE NOT REPLACED AT 3-MONTH INTERVALS. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. AS PER CLINICAL INPUT FROM THE MEDICAL ADVISOR, THE 5 CASES OF ACUTE CHOLANGITIS AND THE 9 CASES OF DRAIN CLOGGING REQUIRED INTERVENTION/ADDITIONAL PROCEDURES AND WERE ATTRIBUTED TO THE USER ERROR OF THE DEVICES. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
DEVICE EVALUATION THE 9 X DEVICES OF UNKNOWN RPN AND LOT NUMBER INVOLVED IN THIS COMPLAINT WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE TO CAPTURE ¿DRAIN CLOGGING + ACUTE CHOLANGITIS¿ (REF. ATT. ¿POZSAR 2005 (HIGHLIGHTED)). ADDITIONAL COMPLAINT FILE PR (B)(4)(MDR#3001845648-2022-00413) WAS OPENED AS A RESULT OF THIS PAPER TO CAPTURE 5 CASES OF ¿STENT DISLOCATION¿. LAB EVALUATION THE DEVICE LAB EVALUATION COULD NOT BE COMPLETED AS THE DEVICE, OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE, WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HISTORICAL DATA REVIEW HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. IFU & LABEL REVIEW AS PER IFU0045-7 CHOLANGITIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH AN ERCP PROCEDURE: ¿THOSE ASSOCIATED WITH ERCP INCLUDE, BUT ARE NOT LIMITED TO: PANCREATITIS, CHOLANGITIS, ASPIRATION, PERFORATION, HAEMORRHAGE, INFECTION, SEPSIS, ALLERGIC REACTION TO CONTRAST OR MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST.¿ AS PER TECHNICAL CONTENT FORM FOR PLASTIC BILIARY STENTS, STENT OCCLUSION (DRAIN CLOGGING) IS A LISTED KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH BILIARY STENT PLACEMENT. IT SHOULD BE NOTED THAT AS PER THE IFU IT STATES IN THE PRECAUTIONS SECTION ¿THIS DEVICE SHOULD NOT BE LEFT INDWELLING FOR MORE THAN THREE MONTHS OR AS DIRECTED BY A PHYSICIAN. PERIODIC EVALUATION IS RECOMMENDED.¿ AS PER THE MEDICAL ADVISOR, THE STENTS WERE ASSOCIATED WITH USER ERROR AS THEY WERE NOT REPLACED AT THE THREE-MONTH INTERVALS STATED IN THE IFU. THE PREVIOUS STENT WAS STILL IN PLACE AND WAS NOT EXCHANGED DURING THE SEQUENTIAL INSERTION OF ANOTHER STENT. WITH THE ABOVE INFORMATION, THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE OF USER ERROR WAS DETERMINED FROM THE AVAILABLE INFORMATION. FROM THE JOURNAL ARTICLE AND CLINICAL INPUT, IT WAS CONFIRMED THAT THE STENTS WERE NOT REPLACED AT 3-MONTH INTERVALS. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. AS PER CLINICAL INPUT FROM THE MEDICAL ADVISOR, THE 5 CASES OF ACUTE CHOLANGITIS AND THE 9 CASES OF DRAIN CLOGGING REQUIRED INTERVENTION/ADDITIONAL PROCEDURES AND WERE ATTRIBUTED TO THE USER ERROR OF THE DEVICES. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
POZSAR ET AL 2005 ¿ ¿ENDOSCOPIC TREATMENT OF SPHINCTEROTOMY-ASSOCIATED DISTAL COMMON BILE DUCT STRICTURES BY USING SEQUENTIAL INSERTION OF MULTIPLE PLASTIC STENTS¿. ALL PATIENTS HAD HIGH-GRADE DISTAL COMMON BILE DUCT STRICTURES EXTENDING UP TO 20 MM PROXIMAL TO THE INTRAMURAL SEGMENT (FIG. 1). A HYDROPHILIC FLUORINATED ETHYLENE-COATED FLEXIBLE GUIDEWIRE (0.035-INCH JAGWIRE; MICROVASIVE ENDOSCOPY, BOSTON SCIENTIFIC CORP, NATICK, MASS) WAS PASSED THROUGH THE STRICTURE, AND THE STRICTURE THEN WAS DILATED WITH POLYETHYLENE 6F, 8F, OR 10F CATHETERS (WILSON-COOK MEDICAL INC, WINSTON-SALEM, NC). THE DIAMETER OF THE DILATION CATHETER WAS DECIDED INDIVIDUALLY, DEPENDING ON THE DIAMETER OF THE STRICTURE AND THAT OF THE PROXIMAL COMMON BILE DUCT. TO EXCLUDE MALIGNANCY, WE OBTAINED INTRADUCTAL BRUSH-CYTOLOGY SPECIMENS FROM ALL PATIENTS. AFTER DILATION OF THE STRICTURE TO THE MAXIMUM POSSIBLE DIAMETER, WE INSERTED A SINGLE PLASTIC 7.5F, 8.5F, OR 10F DIAMETER TEFLON-COATED STENT (WILSON-COOK MEDICAL INC, WINSTON-SALEM, NC) THROUGH THE STRICTURE. DURING THE FIRST STENT PLACEMENT SESSION, OUR BASIC INTENTION WAS TO PLACE THE MAXIMUM DIAMETER SINGLE STENT THAT THE STRICTURE ALLOWED. THE PATIENTS THEN UNDERWENT REPEATED ERCPS AT 3-MONTH INTERVALS. IN ALL ERCP SESSIONS, WE EVALUATED THE LENGTH AND THE DIAMETER OF THE STRICTURE BY THE CHOLANGIO-GRAM. IN ALL STENT-PLACEMENT SESSIONS, WE USED A 6F, PLASTIC GUIDE CATHETER TO PASS THE GUIDEWIRE BEYOND THE STRICTURE ALONG THE STENT INSERTED IN THE PREVIOUS SESSION. THE GUIDEWIRE WAS LEFT IN PLACE, AND WE INSERTED ANOTHER STENT WITH THE MAXIMUM POSSIBLE DIAMETER AFTER REPEATED STEPWISE DILATION OVER THE GUIDEWIRE. OUR BASIC INTENTION WAS TO INSERT THE MAXIMUM POSSIBLE NUMBER OF STENTS AND TO REACH THE MAXIMUM DIAMETER FOR DILATION OF THE STRICTURE. DRAIN CLOGGING WAS OBSERVED IN 9 CASES (16%). THE ACUTE CHOLANGITIS HEALED IN RESPONSE TO STENT EXCHANGE AND THE SYSTEMIC ADMINISTRATION OF ANTIBIOTICS. THERE WERE 5 EPISODES OF ACUTE CHOLANGITIS (9.4%), MAINLY BECAUSE OF DRAIN CLOGGING. CHOLANGITIS WAS CHARACTERIZED BY FEVER, ELEVATED GRANULOCYTE COUNT AND SE ALP, WHICH REACHED AN AVERAGE OF 678 G 73 U/L (RANGE 432-1606 U/L). THERE WERE 5 EPISODES OF ACUTE CHOLANGITIS (9.4%), MAINLY BECAUSE OF DRAIN CLOGGING. CHOLANGITIS WAS CHARACTERIZED BY FEVER, ELEVATED GRANULOCYTE COUNT AND SE ALP, WHICH REACHED AN AVERAGE OF 678 G 73 U/L (RANGE 432-1606 U/L).
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION. ADDITIONAL INFORMATION RECEIVED 24-OCT-2022 CONFIRMED USER ERROR.
SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED DUE TO BELOW CORRECTIONS:1. MEDICAL DEVICE PROBLEM CODE (ANNEX A): FROM A2303 TO A232. COMPONENT CODE (ANNEX G): FROM G07001 TO G04122
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1985093 | UNKNOWN | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |