BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTBACK RE-ENTRY CATHETER

    MDR report key: 2711716 · Received August 23, 2012

    Report

    Report Number
    9616099-2012-00459
    Event Type
    Malfunction
    Date Received
    August 23, 2012
    Date of Event
    August 2, 2012
    Report Date
    August 2, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K043534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 6F ANSEL 55CM SHEATH. THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING PTA WITH AN OUTBACK CTO CATHETER, THE TIP OF THE OUTBACK CATHETER SEPARATED INSIDE OF THE SHEATH. THE TYPE OF PROCEDURE WAS A PERIPHERAL AORTO-ILIO-BIFEMORAL ANGIO WITH PTA OF THE RIGHT SFA. ACCESS WAS VIA THE LEFT FEMORAL. A CONTRALATERAL APPROACH WAS USED. THE TARGET LESION WAS A CTO AND WAS CALCIFIED. THE DEVICE WAS PREPARED AS SPECIFIED BY THE INSTRUCTIONS FOR USE IN A STRAIGHT CONFIGURATION. THE PHYSICIAN ADVANCED A 6F ANSEL 55CM SHEATH OVER THE WIRE THROUGH THE LEFT GROIN. HE THREADED THE OUTBACK OVER THE WIRE AND THROUGH THE SHEATH. THE OUTBACK WENT OVER THE HORN WITH EASE, ONCE OVER THE HORN THE OUTBACK TIP BROKE OFF AND AS THE DOCTOR PULLED THE OUTBACK CATHETER OUT THE TIP REMAINED IN THE RIGHT ILIAC WITHIN THE ANSEL 55CM SHEATH. SHEATH WAS REMOVED WITH OUTBACK TIP INTACT INSIDE THE SHEATH. NEW 6F ANSEL SHEATH WAS INSERTED BACK INTO THE LEFT GROIN. PROCEDURE CONTINUED AND NO COMPLICATIONS RESULTED. WHILE TORQUING THE DEVICE DURING PLACEMENT, THE USER HELD ONTO THE BLACK HANDLE AND THERE WAS NO RESISTANCE ENCOUNTERED WHEN TORQUING THE DEVICE. THE DEVICE DID NOT MAKE A "CLICKING SOUND" AND THEN BEGIN TO TURN FREELY WHILE TORQUING. THE USER DID NOT HOLD ONTO THE LUER HUB ASSEMBLY LOCATED IN FRONT OF THE BLACK HANDLE WHILE TORQUING THE DEVICE. THERE WAS NO DIFFICULTY/RESISTANCE ACTUATING THE PRODUCT. THE PHYSICIAN WAS ABLE TO RE-ENTER THE VESSEL WITH THE GUIDEWIRE. THERE WAS NO RESISTANCE OR DIFFICULTY REMOVING THE OUTBACK FROM THE PATIENT AND NO ABNORMAL FORCE WAS REQUIRED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. ONE NON STERILE CATHETER OUTBACK WAS RECEIVED COILED INSIDE A PLASTIC BAG. BLOOD RESIDUES WERE NOTED IN THE CATHETER. THE TIP WAS BROKEN APPROXIMATED AT 2.5CM FROM DISTAL TIP END AND SEPARATED. DISTAL TIP WAS RIPPED OUT SINCE OUTER LINER PRESENT ELONGATION. DISTAL TIP WAS RETURNED INSIDE UNKNOWN CATHETER SHEATH INTRODUCER (CSI), THE UNKNOWN CSI PRESENTS DAMAGE (LIKE A PUNCTURE). IT WAS NOT POSSIBLE TO MEASURE THE CANNULA USABLE LENGTH DUE TO DAMAGE CONDITION OF THE DEVICE. THE UNIT IS NOT FUNCTIONAL USABLE. NO OTHER ANOMALIES WERE OBSERVED IN THE RETURNED DEVICE. FUNCTIONAL ANALYSIS COULD BE NOT PERFORMED DUE TO THE TIP WAS RIPPED OUT. SEM ANALYSIS WAS PERFORMED TO IDENTIFY THE CAUSE OF BODY SEPARATION. THE BODY EXTERNAL SURFACE PRESENTED EVIDENCE OF ELONGATION AT THE SURROUNDINGS OF THE SEPARATION. ELONGATION IS A COMMON CHARACTERISTIC OF PIECES WHICH WERE STRETCHED/ PULLED UNTIL SEPARATION. STRETCHING/ PULLING AND/ OR TWISTING COULD HAVE BEEN RELATED TO THESE SEPARATION CHARACTERISTICS; HOWEVER THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE EXACT CAUSE OF THE BODY SEPARATION COULD NOT BE CONCLUSIVELY DETERMINED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE CATHETER TIP/DISTAL TIP FRACTURED-SEPARATED/IN PATIENT REPORTED BY THE COSTUMER WAS CONFIRMED; HOWEVER THE BODY EXTERNAL SURFACE PRESENTED EVIDENCE OF ELONGATION AND SCRATCHING AT THE SURROUNDINGS OF THE SEPARATION THE EXACT CAUSE OF THE BODY SEPARATION FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGEST THAT THE DIFFICULTIES EXPERIENCED BY THE CUSTOMER COULD BE RELATED TO THE MANUFACTURING PROCESS, CONTROLS ARE IN PLACE TO PREVENT DEFECTIVE OUTER SHAFT DAMAGES FROM LEAVING THE FACILITY, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED MAY HAVE BEEN CAUSED BY THE OPERATIONAL CONTEXT OF THE DEVICE/PROCEDURAL FACTORS AND IS NOT RELATED TO A PRODUCT QUALITY ISSUE.

    Description of Event or Problem · 1

    DURING PTA WITH AN OUTBACK CTO CATHETER, THE TIP OF THE OUTBACK CATHETER BROKE INSIDE OF THE SHEATH. THE TYPE OF PROCEDURE WAS A PERIPHERAL AORTO-ILIO-BIFEMORAL ANGIO WITH PTA OF THE RIGHT SFA. ACCESS WAS VIA THE LEFT FEMORAL. A CONTRALATERAL APPROACH WAS USED. THE TARGET LESION WAS A CTO AND WAS CALCIFIED. THE DEVICE WAS PREPARED AS SPECIFIED BY THE INSTRUCTIONS FOR USE IN A STRAIGHT CONFIGURATION. THE PHYSICIAN ADVANCED A 6F ANSEL 55CM SHEATH OVER THE WIRE THROUGH THE LEFT GROIN. HE THREADED THE OUTBACK OVER THE WIRE AND THROUGH THE SHEATH. THE OUTBACK WENT OVER THE HORN WITH EASE, ONCE OVER THE HORN, THE OUTBACK TIP BROKE OFF AND AS THE DOCTOR PULLED THE OUTBACK CATHETER OUT THE TIP REMAINED IN THE RIGHT ILIAC WITHIN THE ANSEL 55CM SHEATH. SHEATH WAS REMOVED WITH OUTBACK TIP INTACT INSIDE THE SHEATH. NEW 6F ANSEL SHEATH WAS INSERTED BACK INTO THE LEFT GROIN. PROCEDURE CONTINUED AND NO COMPLICATIONS RESULTED. WHILE TORQUING THE DEVICE DURING PLACEMENT, THE USER HELD ONTO THE BLACK HANDLE AND THERE WAS NO RESISTANCE ENCOUNTERED WHEN TORQUING THE DEVICE. THE DEVICE DID NOT MAKE A "CLICKING SOUND" AND THEN BEGIN TO TURN FREELY WHILE TORQUING. THE USER DID NOT HOLD ONTO THE LUER HUB ASSEMBLY LOCATED IN FRONT OF THE BLACK HANDLE WHILE TORQUING THE DEVICE. THERE WAS NO DIFFICULTY/RESISTANCE ACTUATING THE PRODUCT. THE PHYSICIAN WAS ABLE TO RE-ENTER THE VESSEL WITH THE GUIDEWIRE. THERE WAS NO RESISTANCE OR DIFFICULTY REMOVING THE OUTBACK FROM THE PATIENT AND NO ABNORMAL FORCE WAS REQUIRED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OUTBACK RE-ENTRY CATHETER CTO CATHETER SYSTEMS (DQY) DQY CORDIS DE MEXICO NA 15538689

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR