ZIMMON PANCREATIC STENT
Report
- Report Number
- 3001845648-2023-00659
- Event Type
- Malfunction
- Date Received
- August 29, 2023
- Date of Event
- December 15, 2022
- Report Date
- September 22, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K900923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. MANUFACTURING RECORDS: MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. REVIEW HISTORICAL DATA: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND LABEL: IT SHOULD BE NOTED THAT THE DEVICE WAS USED OFF-LABEL, OUTSIDE ITS INTENDED USE STATED IN THE INSTRUCTIONS FOR USE (IFU0055) "THIS DEVICE IS USED TO DRAIN OBSTRUCTED PANCREATIC DUCTS" AND IN THE NOTES SECTION ¿DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE.¿ WHERE THE OFF LABEL USE OF THE DEVICE IN THIS PROCEDURE IS NOT A STATED USE AS PER THE IFU AND THEREFORE HAS NOT BEING TESTED IN A CLINICAL SETTING. THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. (IFU0055) IT MAY BE NOTED THE DEVICE LABEL INDICATES A 0.035¿ WIRE GUIDE FOR USE WITH THIS DEVICE AND ALL SIMULATED USE TESTING TO DATE HAS BEEN COMPLETED USING A 0.035¿ WIRE GUIDE. AS PER THE INFORMATION REPORTED IN THE PAPER A 0.025" VISI-GLIDE WIRE GUIDE WAS USED WHICH IS USER ERROR DUE TO THE USE OF A NON-RECOMMENDED WIRE GUIDE WITH THE DEVICE. THIS USER ERROR IS SECONDARY TO THE OFF-LABEL USE. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO THE OFF-LABEL USE OF THE SPSOF-5-12 DEVICE, WHEN THE DEVICE IS USED OUTSIDE ITS STATED INTENDED USE, IT MAY LEAD TO OUTCOMES THAT WERE NEVER INTENDED TO HAPPEN AND WERE NEVER STUDIED. THE PANCREATIC STENT WAS PLACED FOLLOWING PANCREATOGRAM SHOWING PARTIAL PANCREAS DIVISUM AND WAS USED TO TREAT THIS LEAKAGE, THIS WAS CONFIRMED AS OFF-LABEL USE BY OUR MEDICAL ADVISOR. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. SUMMARY OF INVESTIGATION: ACCORDING TO THE CUSTOMER, USER ERROR AND OFF LABEL USE CONFIRMED QUANTITY OF 1 DEVICE, CONFIRMED USED. ACCORDING TO THE INITIAL REPORT, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION FINDINGS CONCLUDE THAT A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO THE OFF-LABEL USE OF THE SPSOF-5-12 DEVICE, WHEN THE DEVICE IS USED OUTSIDE ITS STATED INTENDED USE, IT MAY LEAD TO OUTCOMES THAT WERE NEVER INTENDED TO HAPPEN AND WERE NEVER STUDIED. THE PANCREATIC STENT WAS PLACED FOLLOWING PANCREATOGRAM SHOWING PARTIAL PANCREAS DIVISUM AND WAS USED TO TREAT THIS LEAKAGE, THIS WAS CONFIRMED AS OFF-LABEL USE BY OUR MEDICAL ADVISOR.
CHAVAN 2022 ¿ ENDOSCOPIC ULTRASOUND-GUIDED DRAINAGE OF SPLENIC PSEUDOCYST COMMUNICATING WITH PANCREATIC DUCT. EUS-GUIDED DRAINAGE OF PSEUDOCYST WAS PERFORMED WITH CURVY-LINEAR ECHOENDOSCOPE (UCT-180; OLYMPUS LTD, TOKYO, JAPAN) IN LEFT LATERAL POSITION UNDER PROPOFOL SEDATION (VIDEO 1). COLLECTION WAS ACCESSED FROM CARDIA AND WITH 19-GAUGE (EZ SHOT 2, OLYMPUS, TOKYO, JAPAN) NEEDLE. AFTER PUNCTURING COLLECTION DARK BROWN COLOR FLUID WAS ASPIRATED. THROUGH THE NEEDLE 0.025 GUIDEWIRE (VISI- GLIDE, OLYMPUS CORPORATION, TOKYO, JAPAN) WAS COILED INTO CAVITY AND NEEDLE WAS THEN REMOVED. OVER THE GUIDEWIRE 6 FR CYSTOTOME (ENDO-FLEX GMBH DUSSELDORF, GERMANY) WAS PASSED AND TRACT WAS DILATED AND 7FR 7CM DOUBLE PIG TAIL STENT (COOK MEDICAL, BLOOMINGTON, IN, USA) WAS DEPLOYED (¿FIG. 3A¿D). POSTPROCEDURE CT SHOWED SIGNIFICANT REDUCTION IN SIZE OF COLLECTION. PLASTIC STENT WAS PREFERRED OVER THE METAL STENT CONSIDERING THE PUNCTURE POINT IN CARDIA AND LOCATION OF THE PSEUDOCYST, THAT IS, SPLENIC INTRACAPSULAR TO PREVENT SUBSEQUENT COMPLICATIONS (PERFORATION AND BLEEDING). SUBSEQUENTLY, HE UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. INITIALLY PD CANNULATION WAS ATTEMPTED VIA MAJOR PAPILLA WITH A GUIDEWIRE. OVER THE GUIDEWIRE MAJOR PAPILLA SPHINCTEROTOMY (CLEVERCUT 2, OLYMPUS, TOKYO, JAPAN) WAS DONE; HOWEVER, ON FURTHER PUSHING GUIDEWIREWAS REPEATEDLY GETTING CURVED AND CAME OUT THROUGH MINOR PAPILLA. SPHINCTEROTOME WAS THEN EXCHANGED WITH NEEDLE KNIFE AND OVER THE GUIDEWIRE MINOR PAPILLA PAPILLOTOMYWAS PERFORMED. INITIAL GUIDEWIRE WAS THEN WITHDRAWN FROM MAJOR PAPILLA AND PD CANNULATION WAS DONE THROUGH MINOR PAPILLA WITH TAPERED TIP CANNULA. GUIDEWIRE WAS PLACED DEEP INTO THE PD VIA MINOR PAPILLA AND PANCREATOGRAMWAS TAKEN. PANCREATOGRAMSHOWED PARTIAL PANCREAS DIVISUM WITH NORMAL DIAMETER PD AND LEAK FROM TAIL REGION. MINOR PAPILLA SPHINCTEROTOMY DONE AND PANCREATIC STENT (5FR 12CM SINGLE PIGTAIL, COOK MEDICAL, BLOOMINGTON, IN, USA) PLACED ACROSS THE LEAK. OFF LABEL USE: STENT PLACED FOLLOWING PANCREATOGRAM SHOWING PARTIAL PANCREAS DIVISUM AND LEAK. STENT PLACED ACROSS LEAK FROM THE TAIL REGION USER ERROR: USE OF A 0.025 GUIDEWIRE (VISI-GLIDE, OLYMPUS CORPORATION, TOKYO, JAPAN). POSTPROCEDURE PATIENT WAS STABLE AND DISCHARGED ON ORAL ANTIBIOTICS. ON TELEPHONIC CONVERSATION WITH HIM, HE WAS ASYMPTOMATIC AND BOTH PD STENT AND CYSTOGASTRIC STENT WERE REMOVED AT 3 MONTHS AFTER RESOLUTION OF COLLECTION AT HIS PRIMARY CARE CENTER.
SUPPLEMENT REPORT BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 22-SEPT-2023.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2083056 | ZIMMON PANCREATIC STENT | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Male |