BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILIFORM DOUBLE PIGTAIL URETERAL STENT SET

    MDR report key: 7425867 · Received April 12, 2018

    Report

    Report Number
    1820334-2018-00953
    Event Type
    Injury
    Date Received
    April 12, 2018
    Date of Event
    March 8, 2018
    Report Date
    April 25, 2018
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002151468
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED AND THERE WERE NO ADDITIONAL PRODUCT SETS OF THE SAME LOT REMAINING IN INVENTORY. CONSEQUENTLY, A PHYSICAL PRODUCT INVESTIGATION COULD NOT BE CARRIED OUT. A PHOTO WAS PROVIDED. A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, QUALITY CONTROL DATA, AND SPECIFICATIONS WAS PERFORMED. A PHOTO WAS PROVIDED OF THE DEVICE SEPARATED INTO 2 SECTIONS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY REVEALED NO OTHER COMPLAINTS ASSOCIATED WITH LOT NUMBER 7973000. A REVIEW OF THE TENSILE TEST DATA CARRIED OUT AT INCOMING INSPECTION AND BY THE SUPPLIER WAS CARRIED OUT AND THE TENSILE TEST RESULTS WERE FOUND TO BE IN SPECIFICATION. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE THE STERILITY OF THE DEVICE PRIOR TO SHIPPING. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION OF THE SUSPECT DEVICE DID NOT REVEAL ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. THERE IS NO INFORMATION ABOUT THE INITIAL DEVICE PLACEMENT AND HANDLING. PER THE INSTRUCTIONS FOR USE (IFU), IMPROPER HANDLING CAN SERIOUSLY WEAKEN THE STENT. ACUTE BENDING OR OVERSTRESSING DURING PLACEMENT MAY RESULT IN SUBSEQUENT SEPARATION OF THE STENT AT THE POINT OF STRESS AFTER A PROLONGED INDWELLING PERIOD. STENT FRACTURE IS A KNOWN INHERENT RISK OF URETERAL STENT PLACEMENT. BASED ON THE PROVIDED INFORMATION A DEFINITIVE CAUSE OF THE ALLEGED COMPLAINT ISSUE CANNOT BE DETERMINED. MEASURES HAVE BEEN INITIATED TO ADDRESS THE REPORTED FAILURE MODE. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. THE DEVICE WAS NOT RETURNED AND THERE WERE NO ADDITIONAL PRODUCT SETS OF THE SAME LOT REMAINING IN INVENTORY. CONSEQUENTLY, A PHYSICAL PRODUCT INVESTIGATION COULD NOT BE CARRIED OUT. A PHOTO WAS PROVIDED. A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, QUALITY CONTROL DATA, AND SPECIFICATIONS WAS PERFORMED. A PHOTO WAS PROVIDED OF THE DEVICE SEPARATED INTO 2 SECTIONS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY REVEALED NO OTHER COMPLAINTS ASSOCIATED WITH LOT NUMBER 7973000. A REVIEW OF THE TENSILE TEST DATA CARRIED OUT AT INCOMING INSPECTION AND BY THE SUPPLIER WAS CARRIED OUT AND THE TENSILE TEST RESULTS WERE FOUND TO BE IN SPECIFICATION. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE THE STERILITY OF THE DEVICE PRIOR TO SHIPPING. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION OF THE SUSPECT DEVICE DID NOT REVEAL ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. THERE IS NO INFORMATION ABOUT THE INITIAL DEVICE PLACEMENT AND HANDLING. PER THE INSTRUCTIONS FOR USE (IFU), IMPROPER HANDLING CAN SERIOUSLY WEAKEN THE STENT. ACUTE BENDING OR OVERSTRESSING DURING PLACEMENT MAY RESULT IN SUBSEQUENT SEPARATION OF THE STENT AT THE POINT OF STRESS AFTER A PROLONGED INDWELLING PERIOD. STENT FRACTURE IS A KNOWN INHERENT RISK OF URETERAL STENT PLACEMENT. BASED ON THE PROVIDED INFORMATION A DEFINITIVE CAUSE OF THE ALLEGED COMPLAINT ISSUE CANNOT BE DETERMINED. MEASURES HAVE BEEN INITIATED TO ADDRESS THE REPORTED FAILURE MODE. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, OR UNAVAILABLE. PATIENT CODE:  DEVICE FRAGMENTS IN PATIENT ((B)(4)), NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT ((B)(4)). DEVICE CODE: STENT AND BREAK ARE NOT LABELED. PMA/510(K) #: PREAMENDMENT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FILIFORM DOUBLE PIGTAIL URETERAL STENT SET BROKE INTO THREE PIECES WHILE BEING REMOVED DURING A URETERAL STENT EXCHANGE PROCEDURE. THE ENTIRE BROKEN STENT WAS ABLE TO BE REMOVED USING A CYSTOSCOPE AND GRASPERS, AND NO SIGNIFICANT FORCE WAS USED TO REMOVE PORTIONS. THE DEVICE IS NOT AVAILABLE FOR RETURN. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269440 FILIFORM DOUBLE PIGTAIL URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC G15146 00827002151468

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention