BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® POLYURETHANE URETERAL CATHETERS, OPEN TIP

    MDR report key: 18376964 · Received December 21, 2023

    Report

    Report Number
    1018233-2023-09092
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    November 22, 2023
    Report Date
    March 19, 2024
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EYB
    UDI-DI
    10801741126946
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT IS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED, AND FURTHER INVESTIGATION WAS NOT CONCLUSIVE. ALTHOUGH A SPECIFIC ROOT CAUSE CANNOT BE DETERMINED, POTENTIAL ROOT CAUSE FOR THIS EVENT COULD BE, ¿KINKED CATHETER¿. THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "INDICATIONS FOR USE: THE BARD® POLYURETHANE URETERAL CATHETERS ARE INTENDED FOR USE IN THE DRAINAGE OF URINE FROM THE URETER. THE POLYURETHANE URETERAL CATHETER IS INSERTED THROUGH THE URETHRA, INTO THE BLADDER AND UP THROUGH THE URETER. THESE CATHETERS ALSO ALLOW THE DELIVERY OF CONTRAST MEDIA. DIRECTIONS FOR USE: URETERAL CATHETERS ARE DESIGNED IN A VARIETY OF DISTAL TIP CONFIGURATIONS. THE ANATOMICAL CHARACTERISTICS OF THE URETERAL ORIFICE AND PHYSICIAN PREFERENCE SHOULD DETERMINE THE CHOICE OF DESIGN IN A SPECIFIC CLINICAL SITUATION. CLOSED TIP PLACEMENT (PLACED WITHOUT A GUIDEWIRE) AFTER PLACEMENT OF THE CYSTOSCOPE INTO THE BLADDER, THE URETERAL ORIFICE IS LOCATED AND EXAMINED AND A CHOICE OF URETERAL CATHETER IS MADE. THE CATHETER ADAPTER IS SECURED TO THE URETERAL CATHETER, AND THE CATHETER IS FLUSHED TO EVACUATE ALL AIR BUBBLES. UNDER DIRECT VISION, THE CATHETER TIP IS POSITIONED WITHIN THE URETERAL ORIFICE. CONTRAST MEDIA IS THEN INJECTED THROUGH THE URETERAL CATHETER INTO THE URETER. UNDER FLUOROSCOPY, THE URETER IS VISUALIZED AND REQUIRED INTERVENTION DETERMINED. OPEN TIP PLACEMENT (PLACED WITH A GUIDEWIRE) AFTER PLACEMENT OF THE CYSTOSCOPE INTO THE BLADDER, THE URETERAL ORIFICE IS LOCATED AND EXAMINED AND A CHOICE OF URETERAL CATHETER IS MADE. UNDER DIRECT VISION, THE GUIDEWIRE IS POSITIONED WITHIN THE URETERAL ORIFICE. THE URETERAL CATHETER IS INSERTED OVER THE GUIDEWIRE AND ADVANCED INTO THE URETER. THE GUIDEWIRE IS REMOVED AND THE CATHETER ADAPTER IS SECURED TO THE CATHETER. GENTLE ASPIRATION TO EVACUATE AIR FROM THE CATHETER CAN BE PERFORMED AT THIS TIME. CONTRAST MEDIA IS THEN INJECTED THROUGH THE URETERAL CATHETER INTO THE URETER. UNDER FLUOROSCOPY, THE URETER IS VISUALIZED AND REQUIRED INTERVENTION DETERMINED. WARNING: THIS UNIT SHOULD NOT BE USED AS A URETERAL SPLINT. WARNING: THIS IS A SINGLE USE DEVICE. DO NOT RESTERILIZE ANY PORTION OF THIS DEVICE. REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND/OR LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT. CAUTION: DO NOT WITHDRAW URETERAL CATHETER WHILE IT IS DEFLECTED IN ENDOSCOPE. AVOID SHARP BENDING. CAUTION: DO NOT OVER-TIGHTEN THE CATHETER ADAPTER. OVER-TIGHTENING THE CATHETER ADAPTER MAY OCCLUDE THE LUMEN OF THE CATHETER. CAUTION: WHEN USING THE TIGERTAIL¿ CATHETER WITHOUT THE STABILIZING SUPPORT OF A GUIDEWIRE, BE AWARE THAT A MALFUNCTION MAY OCCUR WHERE THE FLEXIBLE TIP MAY DETACH IF EXCESSIVE FORCE IS MADE IN CONTACT WITH THE WALLS OF THE BLADDER, URETER OR RENAL PELVIS. SHOULD THE FLEXIBLE PORTION OF THE CATHETER BECOME DETACHED, RETRIEVE WITH AN ENDOUROLOGY GRASPING DEVICE." H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CYSTOSCOPY PROCEDURE, DOCTOR NOTICED A DEFECTIVE AREA OF THREE OF THE RED, RIGHT SIDED, 5FR X69CM OPEN TIP URETHRAL CATHETERS. ALL FROM THE SAME LOT NUMBER. THEY EXPLAINED THAT THE END OF THE CATHETER WITH THE SCREW CAP ATTACHMENT WAS CRIMPED AND COULD NOT ATTACH GUIDE WIRE TO PASS THROUGH. ALSO STATED THERE WAS DELAY OF PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CYSTOSCOPY PROCEDURE, DOCTOR NOTICED A DEFECTIVE AREA OF THREE OF THE RED, RIGHT SIDED, 5FR X69CM OPEN TIP URETHRAL CATHETERS. ALL FROM THE SAME LOT NUMBER. THEY EXPLAINED THAT THE END OF THE CATHETER WITH THE SCREW CAP ATTACHMENT WAS CRIMPED AND COULD NOT ATTACH GUIDE WIRE TO PASS THROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2168494 BARD® POLYURETHANE URETERAL CATHETERS, OPEN TIP URETERAL CATHETER EYB C.R. BARD, INC. (COVINGTON) -1018233 UNK 10801741126946

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other