BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATHANE SUPRAPUBIC CATHETER SET

    MDR report key: 7352698 · Received March 20, 2018

    Report

    Report Number
    1820334-2018-00600
    Event Type
    Injury
    Date Received
    March 20, 2018
    Date of Event
    February 26, 2018
    Report Date
    July 2, 2018
    Manufacturer
    COOK INC
    Product Code
    KOB
    PMA / PMN Number
    K961904
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON NAME: CATHETER, SUPRAPUBIC (AND ACCESSORIES); CATHETER, NEPHROSTOMY. PRODUCT CODE: KOB. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION/EVALUATION: A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE INVESTIGATION ALSO INCLUDED A REVIEW OF DRAWINGS, THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, AND SPECIFICATIONS. THE DEVICE WAS RETURNED AND VISUAL INSPECTION HAS CONFIRMED THAT THE CATHETER SHAFT RUPTURED INTO TWO SEPARATE PIECES. ALL POSSIBLE MEASUREMENTS WERE WITHIN SPECIFICATIONS (INCLUDING INNER/OUTER DIAMETER) AND THEREFORE WE CANNOT CONFIRM THIS DEVICE TO BE NON-CONFORMING. DURING PRODUCT EXAMINATION, THE LUMEN WAS IDENTIFIED TO BE OCCLUDED WITH BIOMATTER WHICH IS LIKELY RELATED TO THE RUPTURE. IT IS VERY POSSIBLE THAT THE DEVICE BECAME OCCLUDED BECAUSE OF A TORTUROUS ENVIRONMENT THAT THE CATHETER IS NOT DESIGNED FOR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT ABLE TO BE PERFORMED AS THE DEVICE LOT NUMBER WAS NOT PROVIDED. A REVIEW OF COMPLAINT HISTORY FOR THE COMPLAINT DEVICE LOT NUMBER COULD ALSO NOT BE PERFORMED WITHOUT THE LOT NUMBER. A DOCUMENT REVIEW WAS CONDUCTED AND ESTABLISHED THAT PROPER PROCEDURES ARE IN PLACE IN ORDER TO IDENTIFY/PREVENT THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE IFU STATES THE INTENDED USE OF THE DEVICE. THE ULTRATHANE SUPRAPUBIC CATHETER IS USED TO PROVIDE BLADDER DRAINAGE BY PERCUTANEOUS PLACEMENT OF A LOOP CATHETER. THE IFU INSTRUCTS THE USER TO INSERT THE CATHETER VERTICALLY INTO THE BLADDER ON PATIENTS WITHOUT PREVIOUS PELVIC SURGERY, OR AT A 30° ANGLE TOWARD THE SYMPHYSIS PUBIS ON PATIENTS WITH PREVIOUS PELVIC SURGERY. REMOVE THE NEEDLE OBTURATOR AND OBSERVE FOR URINE FLOW. FURTHER INSTRUCTING TO RETRACT THE CATHETER SHAFT UNTIL THE LOOP IS FELT AGAINST THE BLADDER DOME. ADVANCE THE CATHETER APPROXIMATELY 2 CM BACK INTO THE BLADDER TO ALLOW FOR NORMAL MOVEMENT. THE LIKELY CAUSE FOR THE CATHETER RUPTURE IS RELATED TO PRODUCT USE ¿ DID NOT FOLLOW INSTRUCTIONS/LABEL. THE QUALITY ENGINEERING RISK ASSESSMENT DETERMINED THAT NO FURTHER ACTION IS WARRANTED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED A (B)(6) FEMALE PATIENT WITH A HISTORY OF RECURRENT PLEURAL EFFUSION, HAD A CATHETER FROM THE ULTRATHANE SUPRAPUBIC CATHETER SET PLACED IN THE CHEST WALL FOR DRAINAGE BY A PHYSICIAN IN INTERVENTIONAL RADIOLOGY. THE CATHETER HAD BEEN SUTURED IN PLACE IN THE MIDDLE OF THE CATHETER. THE CATHETER CLOTTED OFF AND WHILE ATTEMPTING TO FLUSH THE CATHETER IT CAME APART INSIDE THE PATIENT. THE PATIENT WAS ALREADY SCHEDULED TO HAVE A THORACOSCOPY WITH PARTIAL DECORTICATION PROCEDURE. THE REMAINDER OF THE CATHETER WAS REMOVED FROM THE PATIENT DURING THIS SCHEDULED PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED A (B)(6)-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF RECURRENT PLEURAL EFFUSION, HAD A CATHETER FROM THE ULTRATHANE SUPRAPUBIC CATHETER SET PLACED IN THE CHEST WALL FOR DRAINAGE BY A PHYSICIAN IN INTERVENTIONAL RADIOLOGY. THE CATHETER HAD BEEN SUTURED IN PLACE IN THE MIDDLE OF THE CATHETER. THE CATHETER CLOTTED OFF AND WHILE ATTEMPTING TO FLUSH THE CATHETER IT CAME APART INSIDE THE PATIENT. THE PATIENT WAS ALREADY SCHEDULED TO HAVE A THORACOSCOPY WITH PARTIAL DECORTICATION PROCEDURE. THE REMAINDER OF THE CATHETER WAS REMOVED FROM THE PATIENT DURING THIS SCHEDULED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198473 ULTRATHANE SUPRAPUBIC CATHETER SET KOB COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention