BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK COPE-LOOP CATHETER

    MDR report key: 13800529 · Received March 17, 2022

    Report

    Report Number
    1820334-2022-00409
    Event Type
    Injury
    Date Received
    March 17, 2022
    Date of Event
    April 5, 2012
    Report Date
    November 16, 2022
    Manufacturer
    COOK INC
    Product Code
    LJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE ARTICLE/JOURNAL; APR2012: GNESSIN, E., MANDEVILLE, J.A., HANDA, S.E., ET.AL., 2012, THE UTILITY OF NONCONTRAST COMPUTED TOMOGRAPHY IN THE PROMPT DIAGNOSIS OF POSTOPERATIVE COMPLICATIONS AFTER PERCUTANEOUS NEPHROLITHOTOMY. PMA/510(K) NUMBER = K191498 THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. ADDITIONAL INFORMATION: B3 EVENT DESCRIPTION: IT WAS REPORTED THAT A TOTAL OF 4 PATIENTS UNDERWENT A PNL PROCEDURE THAT RESULTED IN RENAL-PELVIS COMPLICATIONS. ONE PATIENT DEVELOPED A URETERAL CLOT OBSTRUCTION THAT REQUIRED URETERAL STENT PLACEMENT. TWO PATIENTS PROCEDURE RESULTED IN A CALYCEAL PERFORATION / RENAL-PELVIS PERFORATION; BOTH PATIENTS REQUIRED UNSPECIFIED CONSERVATIVE [NON-SURGICAL] TREATMENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. INVESTIGATION - EVALUATION REVIEWS OF INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE CURRENT QUALITY CONTROL PROCEDURES WERE INSPECTED INSTEAD OF THE CONTROLS AT THE TIME OF THE JOURNAL ARTICLE FOR THE SAKE OF RELEVANCE. IT WAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY DEVICE FUNCTIONALITY PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY. A REVIEW OF COMPLAINT HISTORY RECORDS COULD NOT BE COMPLETED DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY. THE INSTRUCTIONS FOR USE (IFU) THAT IS CURRENTLY PACKAGED WITH THE DEVICE WAS REVIEWED FOR RELEVANT INFORMATION PERTAINING TO THE REPORTED FAILURE MODE. CATHETER PLACEMENT: ¿INTRODUCE THE 21-GAUGE NEEDLE BELOW THE TWELFTH RIB, ABOUT FIVE FINGER-BREADTHS FROM THE MIDLINE. ADVANCE THE NEEDLE IN SHORT STEPS TOWARD THE LOWER POLE UNTIL THE NEEDLE IS SEEN MOVING WITH RESPIRATION. WHILE THE PATIENT HOLDS HIS OR HER BREATH, ADVANCE THE NEEDLE NO FURTHER THAN 3CM. IF URINE IS NOT ASPIRATED, REPEAT THE PROCESS USING A SLIGHTLY DIFFERENT ANGLE UNTIL A CALYX IS SUCCESSFULLY PUNCTURED.¿ THERE IS A LIMITED AVAILABILITY OF INFORMATION GIVEN THE DATE THE STUDY WAS PUBLISHED. POTENTIAL CAUSES FOR THE FAILURE MODE ARE PATIENT FACTORS, INADVERTENT USER ISSUES, AND PROCEDURAL ISSUES. THE CURRENT INSTRUCTIONS FOR USE THAT IS PACKAGED WITH THE DEVICE WAS INSPECTED AND DETERMINED TO CONTAIN ADEQUATE INSTRUCTIONS FOR THE APPLICATION OF THE DEVICE AND HOW TO PREVENT MISPLACEMENT/MALPOSITION OF THE DEVICE AND THE POTENTIAL HARMS THAT COULD RESULT FROM SUCH AN OCCURRENCE. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TOTAL OF 4 PATIENTS UNDERWENT A PNL PROCEDURE THAT RESULTED IN RENAL-PELVIS COMPLICATIONS. ONE PATIENT DEVELOPED A URETERAL CLOT OBSTRUCTION THAT REQUIRED URETERAL STENT PLACEMENT. TWO PATIENTS PROCEDURE RESULTED IN A CALYCEAL PERFORATION / RENAL-PELVIS PERFORATION; BOTH PATIENTS REQUIRED UNSPECIFIED CONSERVATIVE [NON-SURGICAL] TREATMENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822520 COOK COPE-LOOP CATHETER LJE CATHETER, NEPHROSTOMY LJE COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention