BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CINCH QR

    MDR report key: 3790282 · Received May 5, 2014

    Report

    Report Number
    1016427-2014-00054
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 11, 2014
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K963171
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR ANALYSIS, HOWEVER, IT HAS NOT YET BEEN RECEIVED. A DEVICE HISTORY RECORD (DHR) REVIEW AND ADDITIONAL INFORMATION ARE PENDING AND WILL BE SUBMITTED WITHIN 30-DAYS UPON RECEIPT. CONCOMITANT DEVICES: CINCH QR SGW WIRE: CATALOG#: 502144, LOT# 70713414. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENT AND THE ASSOCIATED MANUFACTURER REPORT NUMBER IS 1016427-2014-00053.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1016427-2014-00053 AND 1016427-2014-00054. COMPLAINT CONCLUSION: AS REPORTED BY THE SALES REP, TWO CINCH QR SGW WIRES BROKE AND SEPARATED INTO TWO PIECES WHILE BEING REMOVED FROM CASING. THE DEVICES WERE NOT USED IN THE PATIENT AND THERE WAS NO PATIENT INJURY. FOR THE PROCEDURE, TWO CINCH QR SGW WIRES WERE OPENED. HOWEVER, THE WIRES WERE FRACTURED AND SEPARATED WHEN REMOVED FROM THE CASING. THERE WERE NO OTHER DAMAGES OR ANOMALIES NOTED TO THE DEVICES OR PACKAGING. THE DEVICE HAD BEEN HANDLED AND STORED ACCORDING TO THE IFU. THE WIRES HAD BEEN REMOVED FROM THE DISTAL FLOPPY END WITHOUT ANY DIFFICULTY EXPERIENCED OR REQUIRING ANY UNUSUAL FORCE TO REMOVE THE WIRE. THERE WERE NO KINKS/BENDS NOTED ON THE WIRES BEFORE ATTEMPTING TO REMOVE THE WIRES FROM THE CASING. THE PRODUCTS WERE NOT USED IN THE PATIENT, AND THERE WAS NO PATIENT INJURY. A NON-STERILE UNIT OF CARDIOLOGY WIRES & METALS CINCH QR WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. A FRACTURE / SEPARATION WERE FOUND AT DISTAL TIP END. NO OTHER ANOMALIES WERE FOUND. THE CAUSE OF THE FRACTURE COULD NOT BE CONCLUSIVELY DETERMINED. FRACTURE WAS ANALYZED UNDER SEM STATION AND RESULTS SHOWED THAT THE WIRE PRESENTED EVIDENCE OF REVERSE BENDING CONDITIONS. REVERSE BENDING OR FATIGUE FAILURES COULD BE RELATED TO THESE SURFACE CHARACTERISTICS, THESE TYPES OF FAILURES OCCUR DUE TO A TENSILE OVERLOAD. ALSO DUCTILE DIMPLES WERE FOUND IN ALL THE FRACTURES OBSERVED DURING THE ANALYSIS, DUCTILE DIMPLES SUGGEST THAT STRETCHING / PULLING EVENTS WERE OCCURRED. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10214915. THIS PACKAGING LOT CONTAINED (B)(4) UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON JANUARY 22, 2013. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE IFU¿S RECOMMENDED PROCEDURE IS AS FOLLOWS: OPEN THE OUTER BOX AND REMOVE THE POUCH. OPEN THE STERILE POUCH SLOWLY AND REMOVE THE DISPENSING TUBE CONTAINING THE EXTENSION. COMPRESS THE WINGED ALIGNMENT TOOL BETWEEN THE THUMB AND FOREFINGER. THIS HOLDS THE GUIDEWIRE EXTENSION STATIONARY. PLACE THE PROXIMAL END OF THE CORDIS GUIDEWIRE INTO THE FUNNELED END OF THE BLUE WINGED ALIGNMENT TOOL. GENTLY PUSH THE GUIDEWIRE UNTIL FULLY SEATED WITHIN THE EXTENSION WIRE. THE REPORTED ¿GUIDEWIRE / FRACTURED-SEPARATED¿ WAS CONFIRMED AS THE CONDITION OF THE PRODUCT RECEIVED. THE CAUSE OF THE EVENT EXPERIENCED BY THE CUSTOMER COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, PROCEDURAL/HANDLING FACTORS (AS EVIDENCED BY REVERSE BENDING AND FATIGUE FAILURES ON ANALYSIS MIGHT HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. NEITHER THE DEVICE ANALYSIS NOR THE DHR REVIEW INDICATE THAT THE REPORTED COMPLAINT COULD BE RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE, THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE SALES REP, TWO CINCH QR SGW WIRES BROKE AND SEPARATED INTO TWO PIECES WHILE BEING REMOVED FROM CASING. THE DEVICES WERE NOT USED IN THE PATIENT AND THERE WAS NO PATIENT INJURY. FOR THE PROCEDURE, TWO CINCH QR SGW WIRES WERE OPENED. HOWEVER, THE WIRES WERE FRACTURED AND SEPARATED WHEN REMOVED FROM THE CASING. THERE WERE NO OTHER DAMAGES OR ANOMALIES NOTED TO THE DEVICES OR PACKAGING. THE DEVICE HAD BEEN HANDLED AND STORED ACCORDING TO THE IFU. THE WIRES HAD BEEN REMOVED FROM THE DISTAL FLOPPY END WITHOUT ANY DIFFICULTY EXPERIENCED OR REQUIRING ANY UNUSUAL FORCE TO REMOVE THE WIRE. THERE WERE NO KINKS/BENDS NOTED ON THE WIRES BEFORE ATTEMPTING TO REMOVE THE WIRES FROM THE CASING. THE PRODUCTS WERE NOT USED IN THE PATIENT, AND THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266433 CINCH QR CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA 71212439

    Patients

    Seq Age Sex Outcome Treatment
    1