BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILIFORM DOUBLE PIGTAIL URETERAL STENT SET

    MDR report key: 7438598 · Received April 17, 2018

    Report

    Report Number
    1820334-2018-00954
    Event Type
    Injury
    Date Received
    April 17, 2018
    Date of Event
    March 2, 2018
    Report Date
    May 1, 2018
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002151468
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION: THE DEVICE WAS NOT RETURNED AND THERE WERE NO PHOTOS OF THE COMPLAINT PRODUCT WERE PROVIDED. THERE WERE NO ADDITIONAL PRODUCT SETS REMAINING OF THE SAME LOT CONSEQUENTLY A PHYSICAL PRODUCT INVESTIGATION COULD NOT BE CARRIED OUT. A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, QUALITY CONTROL DATA, AND SPECIFICATIONS WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY REVEALED ONE OTHER COMPLAINT ASSOCIATED WITH LOT NUMBER 8211194. THE SECOND COMPLAINT WAS FROM THE SAME FACILITY AND FOR THE SAME FAILURE MODE. A DOCUMENT REVIEW DID NOT IDENTIFY ANY ANOMALIES WITH THE MANUFACTURING PROCESS OR ANY NON-CONFORMANCES. THE TUBING USED FOR THE STENT IS SUPPLIED WITH TENSILE TEST DATA THAT INDICATED IT MET SPECIFICATION. RAW MATERIAL INCOMING INSPECTION ALSO CARRIED OUT TENSILE TESTING ON THE SAME MATERIAL. THE DATA WAS REVIEWED FOR THE COMPLAINT LOT AND FOUND TO MEET SPECIFICATION. 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. INVESTIGATION ¿ EVALUATION: THE DEVICE WAS NOT RETURNED AND THERE WERE NO PHOTOS OF THE COMPLAINT PRODUCT WERE PROVIDED. THERE WERE NO ADDITIONAL PRODUCT SETS REMAINING OF THE SAME LOT CONSEQUENTLY A PHYSICAL PRODUCT INVESTIGATION COULD NOT BE CARRIED OUT. A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, QUALITY CONTROL DATA, AND SPECIFICATIONS WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY REVEALED ONE OTHER COMPLAINT ASSOCIATED WITH LOT NUMBER 8211194. THE SECOND COMPLAINT WAS FROM THE SAME FACILITY AND FOR THE SAME FAILURE MODE. A DOCUMENT REVIEW DID NOT IDENTIFY ANY ANOMALIES WITH THE MANUFACTURING PROCESS OR ANY NON-CONFORMANCES. THE TUBING USED FOR THE STENT IS SUPPLIED WITH TENSILE TEST DATA THAT INDICATED IT MET SPECIFICATION. RAW MATERIAL INCOMING INSPECTION ALSO CARRIED OUT TENSILE TESTING ON THE SAME MATERIAL. THE DATA WAS REVIEWED FOR THE COMPLAINT LOT AND FOUND TO MEET SPECIFICATION. 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

    (B)(4). 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 DURING THE STENT RETRIEVAL PROCEDURE AND THE USER USED FORCEPS TO RETRIEVE THE BROKEN PIECE OF THE STENT IMMEDIATELY. THE STENT HAD BEEN IMPLANTED FOR AROUND 2.5 MONTHS IN THE PATIENT. IT WAS REPORTED THAT THE PRODUCT WILL NOT BE RETURNED AS IT WAS DISCARDED. 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
    279410 FILIFORM DOUBLE PIGTAIL URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC G15146 00827002151468

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention