BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSPORT LOW PROFILE GASTROSTOMY DEVICE

    MDR report key: 8926215 · Received August 23, 2019

    Report

    Report Number
    1037905-2019-00491
    Event Type
    Malfunction
    Date Received
    August 23, 2019
    Date of Event
    June 28, 2019
    Report Date
    July 30, 2019
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNT
    UDI-DI
    00827002246126
    PMA / PMN Number
    K920579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK PASSPORT LOW PROFILE GASTROSTOMY DEVICE. THE PATIENT UNDERWENT AN ATTEMPT TO CHANGE A GASTROSTOMY DEVICE (PASS-20-1.7), HOWEVER, IT WAS NOT POSSIBLE BECAUSE DURING THE TRACTION OF THE BUTTON TIP FOR INTRODUCTION INTO THE STOMACH, IT [THE BUTTON] WAS INJURED [TORN] EVEN WITH MINIMAL TRACTION. THE PROCEDURE WAS COMPLETED USING ANOTHER MATERIAL." THE PHOTO PROVIDED DEPICTS A HOLE IN THE BOTTOM OF THE BUTTON. THE PHOTO RECEIVED INDICATES THAT THE TIP OF THE PASSPORT IS MISSING. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019: THE RED SUBSTANCE IN THE PHOTO IS BLOOD AND THE DEVICE DID COME IN CONTACT WITH THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

    Additional Manufacturer Narrative · 1

    NON-HEALTHCARE PROFESSIONAL. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS PERFORMED ONLY BY THE PICTURE PROVIDED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. PER THE PICTURE PROVIDED, THE DEVICE BOLSTER HAS BEEN PUNCTURED AND A PORTION OF THE DISTAL TIP IS MISSING. RED DISCOLORATION CAN BE SEEN INSIDE THE BOLSTER. WITHOUT THE PRODUCT OR SUBSTANTIAL EVIDENCE TO CONTRADICT THE COMPLAINT, IT IS CONSIDERED CONFIRMED BASED SOLELY ON THE PHOTO PROVIDED AND STATEMENTS DESCRIBING THE EVENT. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE PROVIDES THE FOLLOWING INFORMATION: "GENEROUSLY LUBRICATE STOMA SITE AND CONICAL TIP OF SELECTED PASSPORT USING WATER SOLUBLE LUBRICANT ONLY. CAUTION: USE OF NON-WATER SOLUBLE LUBRICANT MAY CAUSE DAMAGE TO PASSPORT. LUBRICATE OBTURATOR AND INSERT IT THOUGH VALVE OPENING ON TOP OF DEVICE. ADVANCE OBTURATOR INTO CONICAL TIP. CONTINUE ADVANCING OBTURATOR TO ELONGATE TIP. FLATTEN ELONGATED CONICAL TIP AGAINST OBTURATOR TO AID INSERTION. USING A SLIGHT TWISTING MOTION IN DIRECTION OF STOMA TRACT, ADVANCE ELONGATED CONICAL TIP FULLY INTO STOMACH." THE OBTURATOR BEING OFF CENTERED WHEN THE DEVICE WAS ELONGATED FOR PLACEMENT COULD HAVE CONTRIBUTED TO THIS OCCURRENCE. IF THE PASSPORT DEVICE WAS SUBJECTED TO EXCESSIVE PRESSURE DURING ELONGATION FOR PLACEMENT, THIS COULD HAVE CONTRIBUTED TO THE REPORTED OCCURRENCE. PRIOR TO DISTRIBUTION, ALL PASSPORT-LOW PROFILE GASTROSTOMY TUBES ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK PASSPORT LOW PROFILE GASTROSTOMY DEVICE. THE PATIENT UNDERWENT AN ATTEMPT TO CHANGE A GASTROSTOMY DEVICE, HOWEVER, IT WAS NOT POSSIBLE BECAUSE DURING THE TRACTION OF THE BUTTON TIP FOR INTRODUCTION INTO THE STOMACH, IT [THE BUTTON] WAS INJURED [TORN] EVEN WITH MINIMAL TRACTION. THE PROCEDURE WAS COMPLETED USING ANOTHER MATERIAL." THE PHOTO PROVIDED DEPICTS A HOLE IN THE BOTTOM OF THE BUTTON. THE PHOTO RECEIVED INDICATES THAT THE TIP OF THE PASSPORT IS MISSING. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721438 PASSPORT LOW PROFILE GASTROSTOMY DEVICE KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES) KNT COOK ENDOSCOPY G24612 W4144217 00827002246126

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR