BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMON BILIARY STENT

    MDR report key: 8919749 · Received August 22, 2019

    Report

    Report Number
    3001845648-2019-00429
    Event Type
    Injury
    Date Received
    August 22, 2019
    Report Date
    August 22, 2019
    Manufacturer
    COOK INC
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED TO CIRL FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WILL BE COMPLETE. PRIOR TO DISTRIBUTION ALL ZIMMON BILIARY STENT DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR THE ZIMMON BILIARY STENT DEVICES COULD NOT BE COMPLETE AS THE RPN & LOT NUMBER ARE UNKNOWN. AS PER INSTRUCTIONS FOR USE IFU0045-7 WHICH ACCOMPANIES THIS DEVICE: PERFORATION IS LISTED AS A POTENTIAL COMPLICATION. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. PERFORATION IS LISTED AS A POTENTIAL COMPLICATION AS PER THE IFU. COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THERE WAS PERFORATION OF THE ABDOMEN DURING STENT PLACEMENT WHICH WAS CLOSED WITH A METALLIC CLIP. "CT ABDOMEN REVEALED FEW AIR POCKETS AROUND HEPATICO-JEJUNOSTOMY WITHOUT ANY FLUID COLLECTION. SUBSEQUENTLY ON 3RD DAY LIVER FUNCTIONS NORMALIZED AND PATIENT WAS DISCHARGED. ON TWO MONTH FOLLOW UP, PATIENT WAS ASYMPTOMATIC WITH NORMAL ABDOMINAL ULTRASONOGRAPHY." COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    "SHE UNDERWENT SBE ASSISTED ERCP. THE SBE SYSTEM CONSISTS OF A ENTEROSCOPE (SIF-Q180; OLYMPUS MEDICAL SYSTEMS, JAPAN), OVERTUBE WITH A BALLOON (ST-SB1; OLYMPUS), AND A BALLOON CONTROLLER (XMAJ-1725; OLYMPUS). THE ENTEROSCOPE HAS A WORKING LENGTH OF 200 CM AND WORKING CHANNEL DIAMETER OF 2.8 MM. THROUGH ROUX LIMB AFFERENT LIMB WAS INTUBATED WHICH REVEALED PIN POINT STRICTURE AT HEPATICO-JEJUNOSTOMY ANASTOMOTIC STRICTURE. STRICTURE WAS CANNULATED USING SOEHENDRA BILIARY DILATION CATHETER (COOK MEDICAL INC.). CHOLANGIOGRAM SHOWED TIGHT STRICTURE AT WITH DILATED IHBR. STRICTURE DILATATION WAS PERFORMED USING 12 MM DIAMETER BALLOON CATHETER (QUANTUM TTC BILIARY BALLOON DILATORS; COOK MEDICAL, INC. USA) OVER THE GUIDE-WIRE. BILIOENTERIC ANASTOMOSIS WAS WIDENED BY ENDOSCOPIC STRICTUROPLASTY WITH NEEDLE KNIFE (ZIMMON NEEDLE KNIFE PAPILLOTOME, COOK MEDICAL INC.). SUBSEQUENTLY TO PREVENT RECURRENCE OF STRICTURE TWO 7FR DOUBLE PIG TAIL PLASTIC STENTS (COOK MEDICAL, INC. USA) WERE PUT ACROSS THE STRICTURE. DURING STENT PLACEMENT, PERFORATION SHOWING PERITONEUM NEAR BILIOENTERIC ANASTOMOSIS WAS NOTICED. SUBSEQUENTLY PERFORATION WAS CLOSED WITH METALLIC CLIP (RESOLUTIONTM CLIP, BOSTON SCIENTIFIC INC. USA). BOTH THE EDGES WERE SECURED CLOSELY BY CLIP." FDA MDR REPORTING REQUIRED: COSERVATIVELY ASSESSED AS REPORTABLE UNTIL CONFIRMATION CAN BE MADE REGARDING WHICH DEVICE CAUSED THE PERFORATION, THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.1 AS INTERVENTION WAS REQUIRED (PERFORATION WAS CLOSED WITH METALLIC CLIP).

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    "SHE UNDERWENT SBE ASSISTED ERCP. THE SBE SYSTEM CONSISTS OF A ENTEROSCOPE (SIF-Q180; OLYMPUS MEDICAL SYSTEMS, (B)(4)), OVERTUBE WITH A BALLOON (ST-SB1; OLYMPUS), AND A BALLOON CONTROLLER (XMAJ-1725; OLYMPUS). THE ENTEROSCOPE HAS A WORKING LENGTH OF 200 CM AND WORKING CHANNEL DIAMETER OF 2.8 MM. THROUGH ROUX LIMB AFFERENT LIMB WAS INTUBATED WHICH REVEALED PIN POINT STRICTURE AT HEPATICO-JEJUNOSTOMY ANASTOMOTIC STRICTURE. STRICTURE WAS CANNULATED USING SOEHENDRA BILIARY DILATION CATHETER (COOK MEDICAL INC.). CHOLANGIOGRAM SHOWED TIGHT STRICTURE AT WITH DILATED IHBR. STRICTURE DILATATION WAS PERFORMED USING 12 MM DIAMETER BALLOON CATHETER (QUANTUM TTC BILIARY BALLOON DILATORS; COOK MEDICAL, INC. USA) OVER THE GUIDE-WIRE. BILIOENTERIC ANASTOMOSIS WAS WIDENED BY ENDOSCOPIC STRICTUROPLASTY WITH NEEDLE KNIFE (ZIMMON NEEDLE KNIFE PAPILLOTOME, COOK MEDICAL INC.). SUBSEQUENTLY TO PREVENT RECURRENCE OF STRICTURE TWO 7FR DOUBLE PIG TAIL PLASTIC STENTS (COOK MEDICAL, INC. USA) WERE PUT ACROSS THE STRICTURE. DURING STENT PLACEMENT, PERFORATION SHOWING PERITONEUM NEAR BILIOENTERIC ANASTOMOSIS WAS NOTICED. SUBSEQUENTLY PERFORATION WAS CLOSED WITH METALLIC CLIP (RESOLUTION TM CLIP, BOSTON SCIENTIFIC INC. USA). BOTH THE EDGES WERE SECURED CLOSELY BY CLIP." FDA MDR REPORTING REQUIRED: CONSERVATIVELY ASSESSED AS REPORTABLE UNTIL CONFIRMATION CAN BE MADE REGARDING WHICH DEVICE CAUSED THE PERFORATION, THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ AS INTERVENTION WAS REQUIRED (PERFORATION WAS CLOSED WITH METALLIC CLIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715895 ZIMMON BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention