CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
Report
- Report Number
- 3001845648-2022-00722
- Event Type
- Injury
- Date Received
- October 25, 2022
- Date of Event
- October 13, 2021
- Report Date
- April 26, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- KNS
- PMA / PMN Number
- K022595
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
DEVICE EVALUATION THE CST-10 DEVICES OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS COMPLAINT FILE WAS 1 OUT OF 4 OPENED FROM THE JAGIELSKI 2021 LITERATURE PAPER IN RELATION TO THE OFF LABEL USE OF 20 CST-10 DEVICES OF UNKNOWN LOT NUMBER WHERE THE PATIENT EXPERIENCED GASTROINTESTINAL BLEEDING. 377419 - JAGIELSKI 2021 - ¿OFF LABEL USE OF ZIMMON BILIARY STENT¿, 377418 - JAGIELSKI 2021 - ¿OFF LABEL USE OF CST + GASTROINTESTINAL BLEEDING.¿, 377420 - JAGIELSKI 2021 - ¿OFF LABEL USE OF CST.¿ 377665 - JAGIELSKI 2021 - "OFF LABEL USE - NASAL DRAINAGE TUBE". LAB EVALUATION: N/A. DOCUMENT REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION, ALL CST-10 DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. AS THE LOT NUMBERS ARE UNKNOWN A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0005 WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO; "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE AS THERE WAS 20 CASES OF CST-10 USED IN THE TREATMENT OF WOPN. THIS DEVICE IS INDICATED FOR TREATMENT OF PANCREATIC PSEUDOCYSTS ONLY WHICH WOULD BE CONSIDERED OFF LABEL USE. (IFU0005). OFF LABEL USE COMPLAINTS ARE CONSIDERED TO BE UNFORESEEN MISUSE. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. IMAGE REVIEW: N/A. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD BE ATTRIBUTED TO OFF-LABEL USE AS THERE WAS 20 CASES OF CST-10 USED IN THE TREATMENT OF WOPN. THIS DEVICE IS INDICATED FOR TREATMENT OF PANCREATIC PSEUDOCYSTS ONLY WHICH WOULD BE CONSIDERED OFF LABEL USE, AS PER IFU0005 "THIS DEVICE IS DESIGNED TO ELECTROSURGICALLY PUNCTURE A HOLE IN THE TRANSGASTRIC OR TRANSDUODENAL WALL AND INTO A PANCREATIC PSEUDOCYST, WHEN IT IS VISIBLY BULGING INTO THE GASTROINTESTINAL TRACT " SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENTS DID EXPERIENCE GASTROINTESTINAL BLEEDING. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
JAGIELSKI ET AL 2021, - ¿THE ROLE OF LUMEN-APPOSING METAL STENTS IN TRANSMURAL ENDOSCOPIC DRAINAGE OF POSTINFLAMMATORY PANCREATIC AND PERIPANCREATIC FLUID COLLECTIONS¿. TRANSMURAL DRAINAGE WITH THE SINGLE TRANSLUMINAL GATEWAY TECHNIQUE (SGT) (167 PATIENTS). PLACEMENT OF THE PANCREA-TICOGASTRIC OR PANCREATICODUODENAL ANASTOMOSIS IN THE FORM OF TRANSMURAL CYSTOSTOMY WAS PERFORMED UNDER EUS GUID-ANCE. THE ANASTOMOSIS BETWEEN THE GASTROINTESTINAL LUMEN AND THE COLLECTION CAVITY WAS CREATED WITH A 10 FR CYSTOTOME (CYSTOTOME CST-10, COOK ENDOSCOPY INC., NORTH CAROLINA, USA) AND THEN DILATED WITH A HIGH-PRESSURE BALLOON WITH A DIAMETER OF UP TO 15 MM (COOK ENDOSCOPY OR BOSTON SCIEN-TIFIC). THROUGH THE STOMY, A TRANSMURAL METAL ENDOPROSTHESIS (LAMS) WAS INSERTED, MEASURING 16 MM IN DIAMETER AND 20 MM, 30 MM, OR 40 MM IN LENGTH (TAEWOONG MEDICAL OR OLYMPUS). FOR ACTIVE TRANSMURAL DRAINAGE, A 7 FR OR 8.5 FR NASAL DRAIN (COOK ENDOSCOPY) AND 7 FR OR 8 FR DOUBLE-PIGTAIL STENTS (COOK ENDOSCOPY) WERE INSERTED INTO THE COLLECTION CAVITY THROUGH THE LAMS. IN THE CASE OF PASSIVE TRANSMURAL DRAINAGE, ONLY 7 FR OR 8.5 FR DOUBLE-PIGTAIL STENTS (COOK ENDOSCOPY) WERE USED THROUGH LAMS. MULTIPLE TRANSLUMINAL GATEWAY TECHNIQUE (MTGT) (90 PATIENTS). IN PATIENTS WITH ADDITIONAL TRANSMURAL STOMY CREATED BETWEEN THE COLLECTION AND LUMEN OF THE GASTROINTESTINAL TRACT, THE PLACEMENT OF THE ANASTOMOSIS WAS ALSO DECIDED UNDER EUS GUIDANCE. THE TRANSMURAL CYSTOSTOMY WAS CRE-ATED WITH A 10 FR CYSTOSTOME (CYSTOTOME CST-10, COOK ENDOSCOPY) AND EXPANDED WITH A HIGH-PRESSURE BALLOON WITH A DIAMETER OF UP TO 15 MM (BOSTON SCIENTIFIC, MASSACHUSETTS, USA). NEXT, A METAL ENDOPROSTHESIS (LAMS) WITH A DIAMETER OF 16 MM AND LENGTH OF 30 MM OR 40 MM (TAEWOONG MEDI-CAL OR OLYMPUS) WAS INSERTED TRANSMURALLY. DEPENDING ON THE TYPE OF DRAINAGE, A 7 FR OR 8.5 FR NASAL (WILSON-COOK) AND/OR 7 FR OR 8 FR DOUBLE-PIGTAIL STENT (WILSON COOK) DRAIN WAS INSERTED THROUGH THE ENDOPROSTHESIS AND INTO THE COLLEC-TION LUMEN. GASTROINTESTINAL BLEEDING: BLEEDING INTO THE UPPER GAS-TROINTESTINAL TRACT, WHICH WAS OBSERVED IN 20 PATIENTS. FOR ALL CASES, THE CAUSE WAS BLEEDING FROM THE PPFC THROUGH TRANS-MURAL CYSTOSTOMY INTO THE GASTROINTESTINAL LUMEN. TREATMENT: CONSERVATIVE TREATMENT WITH BLOOD TRANSFUSIONS AND BLOOD DERIVATIVES PROVED SUCCESSFUL IN 8 PATIENTS WITH GASTRO-INTESTINAL BLEEDING DURING ONGOING TRANSMURAL DRAINAGE. ENDOSCOPIC TREATMENT WITH HEMOSTATIC POWDER (HEMOSPRAY, COOK ENDOSCOPY) SPRAYED INTO THE COLLECTION CAVITY WAS EFFECTIVE FOR MANAGING BLEEDING IN 5 PATIENTS. ANOTHER 5 PATIENTS REQUIRED ENDOVASCULAR TREATMENT WITH EMBOLIZATION OF THE PERFORATED VESSEL (4 CASES) OR INSERTION OF A STENT GRAFT TO BYPASS THE SITE OF VASCULAR RUPTURE (1 CASE). AMONG THE PATIENTS WHO RECEIVED ENDOVASCULAR TREAT-MENT, 4 HAD BLEEDING FROM THE SPLENIC ARTERY AND 1 FROM THE GASTRODUODENAL ARTERY. DUE TO THE INEFFICACY OF MINIMALLY INVASIVE BLEEDING MANAGEMENT TECHNIQUES, 2 PATIENTS REQUIRED SURGICAL TREATMENT. DURING LAPAROTOMY, THE BLEEDING ARTERY (THE GASTRODUODENAL ARTERY IN 1 CASE AND THE SPLENIC ARTERY IN 1 CASE) WAS LIGATED USING THE STICK TIE TECHNIQUE. THIS FILE WILL CAPTURE OFF LABEL USE OF CST: USED IN THE TREATMENT OF WOPN. (THIS DEVICE IS INDICATED FOR TREATMENT OF PANCREATIC PSEUDOCYSTS ONLY.) + 20 CASES OF GASTROINTESTINAL BLEEDING. GASTROINTESTINAL BLEEDING: BLEEDING INTO THE UPPER GAS-TROINTESTINAL TRACT, WHICH WAS OBSERVED IN 20 PATIENTS. FOR ALL CASES, THE CAUSE WAS BLEEDING FROM THE PPFC THROUGH TRANS-MURAL CYSTOSTOMY INTO THE GASTROINTESTINAL LUMEN. TREATMENT: CONSERVATIVE TREATMENT WITH BLOOD TRANSFUSIONS AND BLOOD DERIVATIVES PROVED SUCCESSFUL IN 8 PATIENTS WITH GASTRO-INTESTINAL BLEEDING DURING ONGOING TRANSMURAL DRAINAGE. ENDOSCOPIC TREATMENT WITH HEMOSTATIC POWDER (HEMOSPRAY, COOK ENDOSCOPY) SPRAYED INTO THE COLLECTION CAVITY WAS EFFECTIVE FOR MANAGING BLEEDING IN 5 PATIENTS. ANOTHER 5 PATIENTS REQUIRED ENDOVASCULAR TREATMENT WITH EMBOLIZATION OF THE PERFORATED VESSEL (4 CASES) OR INSERTION OF A STENT GRAFT TO BYPASS THE SITE OF VASCULAR RUPTURE (1 CASE). AMONG THE PATIENTS WHO RECEIVED ENDOVASCULAR TREATMENT, 4 HAD BLEEDING FROM THE SPLENIC ARTERY AND 1 FROM THE GASTRODUODENAL ARTERY. DUE TO THE INEFFICACY OF MINIMALLY INVASIVE BLEEDING MANAGEMENT TECHNIQUES, 2 PATIENTS REQUIRED SURGICAL TREATMENT. DURING LAPAROTOMY, THE BLEEDING ARTERY (THE GASTRODUODENAL ARTERY IN 1 CASE AND THE SPLENIC ARTERY IN 1 CASE) WAS LIGATED USING THE STICK TIE TECHNIQUE.
SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS ON THE 26-APR-2023.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2894754 | CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE | KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC | KNS | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Male | Required Intervention |