BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE 18 LP LOW PROFILE BALLOON DILATATION CATHETER

    MDR report key: 2221245 · Received August 17, 2011

    Report

    Report Number
    1820334-2011-00461
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 26, 2011
    Manufacturer
    COOK, INC.
    Product Code
    DQY
    PMA / PMN Number
    K073378
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DEVICE SEPARATION IS NOT SPECIFICALLY LABELED IN THE IFU. EVENT EVALUATION: PRODUCT WAS RETURNED IN A USED AND DAMAGED CONDITION. PER (B)(4), BALLOON BURST, COMPLIANCE, AND FATIGUE VERIFICATION TESTING PERFORMED. RBP OF 11 ATM IS DOCUMENTED IN THE IFU AND LABEL. THE DEVICE IS INSPECTED TO ENSURE BALLOON IS UNDAMAGED. VENDOR BURST TESTS (B)(4) BALLOONS PER LOT. EACH DEVICE IS LEAK TESTED AND THE BALLOON BONDS ARE EXAMINED. EACH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) THAT DELINEATES THE PROPER INFLATION AND DEFLATION PROCEDURES. THESE DETECTION ACTIVITIES WILL LIKELY RESULT IN A VERY HIGH PROBABILITY OF DETECTION TO PREVENT RUPTURE. THE EVENT DESCRIPTION FOR THIS CASE WHILE LENGTHY IS UNFORTUNATELY SHORT OF DETAILS. INFO REGARDING THE INFLATION DEVICE AND PRESSURE AT RUPTURE WAS NOT REPORTED. THE NUMBER OF INFLATIONS NOR WAS PT ANATOMY DESCRIBED. THE RATED BURST PRESSURE OF THE DEVICE IS 12 ATM. LESION MORPHOLOGY AND/OR OVER-INFLATION MAY CONTRIBUTE TO BALLOON RUPTURE. THE PT'S AGE, (B)(6) MAKES LESION MORPHOLOGY A POSSIBLE CONTRIBUTING CAUSE. THE IFU RECOMMENDS THAT WHEN USED IN DIFFICULT ANATOMY AND LESIONS MAY REQUIRE THE USE OF A BALLOON WITH A HIGHER RATED BURST PRESSURE (PLUS OR MINUS 15 ATM). THE EVENT DESCRIPTION STATES THAT THE BALLOON "BROKE AWAY" DURING WITHDRAWAL. IT IS UNLIKELY THAT THIS SCENARIO COULD OCCUR UNLESS THE BALLOON HAD BEEN PREVIOUSLY COMPROMISED. ADDITIONALLY THE RETURNED PRODUCT HAD TO BE SURGICALLY REMOVED. THIS COULD HAVE RESULTED IN ADDITIONAL DAMAGE. NEVERTHELESS AN EXAMINATION OF THE RETURNED DEVICE COULD FIND NO SPECIFIC REASON OR ROOT CAUSE FOR THE DEVICE FAILURE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. NO ACTION IS NECESSARY AT THIS TIME PER QERA, THERE IS INSUFFICIENT RISK.

    Description of Event or Problem · 1

    ON (B)(6) 2011, WHILST THE REP WAS AT THE (B)(6) WITH X-RAY DEPARTMENT SISTER, SHE WAS APPROACHED BY A DR, WHO WAS CONCERNED THAT ANOTHER MFR'S REP WANTED TO SEE HIM REGARDING AN (B)(4) REPORT ABOUT A BALLOON ISSUE, HE COMMENTED THAT IT WAS NOT THEIR BALLOON BUT WAS A COOK BALLOON. REP ASKED WHAT HAD HAPPENED AND WAS TOLD AS FOLLOWS.... ON (B)(6), DR WAS PERFORMING A BILATERAL ILIAC ANGIOPLASTY. HE USED A 4FR TERUMO SHEATH AND A COOK PTA4 BALLOON; FOLLOWING THE ANGIOPLASTY, HE ATTEMPTED TO REMOVE THE PTA4 BALLOON. WHILST PULLING THE 18LP BALLOON THROUGH THE TERUMO 4FR SHEATH, PART OF THE BALLOON 'BROKE AWAY'. ON X-RAY HE COULD SEE THE RADIOPAQUE MARKER ON THE SEGMENT OF BALLOON MATERIAL THAT HAD 'BROKEN OFF'. HE ATTEMPTED TO RETRIEVE THE BALLOON MATERIAL WITH A BARD 'PAT RAT' BUT FAILED TO CAPTURE IT. THE PT WAS SENT BACK TO THE WARD. DR THEN LEFT THE DEPARTMENT TO START HIS HOLIDAY. TWO DAYS LATER, THE PT PRESENTED WITH AN OCCLUSION AT THE ORIGIN OF THE RIGHT TIBIAL PERITONEAL ARTERY. THE OCCLUSION WAS CAUSED BY THE REMAINING BALLOON MATERIAL AND WAS SURGICALLY REMOVED BY THE VASCULAR SURGEON. THE VASCULAR SURGEON REPORTED THE INCIDENT TO (B)(4) (WITHOUT DISCUSSION WITH DR WHO WAS ON HOLIDAY). THE VASCULAR SURGEON REPORTED THE BALLOON SEGMENT TO BE FROM A BOSTON BALLOON. HE CONTACTED BOSTON AND SENT THE BALLOON SEGMENT TO THEM WITH A COMPLAINT FOR INVESTIGATION. ON RETURN FROM HIS HOLIDAY DR HAD A MESSAGE FROM THE BOSTON REP WANTING TO DISCUSS THE (B)(4) REPORT AND TAKE DETAILS OF THE INCIDENT, THIS WAS THE FIRST OCCASION THAT DR HAD BEEN AWARE OF THE REPORT TO (B)(4). DR HAS CONTACTED THE OTHER MANUFACTURER'S REP TO INFORM THEM THAT IT WAS NOT THEIR BALLOON BUT IT WAS A COOK BALLOON. TODAY DR ASKED COOK REP IF THE 7X4 BALLOON WAS COMPATIBLE WITH A 4FR SHEATH. IT WAS; HE ASKED WHY THEN WAS HE NOT ABLE TO REMOVE IT FROM THE TERUMO 4FR SHEATH? REP DOESN'T KNOW. DR DID NOT WANT TO MAKE A COMPLAINT ABOUT THE INCIDENT; HE DID WANT ME TO CHECK IF OUR 18LP 7X4 IS COMPATIBLE WITH A TERUMO 4FR SHEATH. PT OUTCOME WAS NOT PROVIDED BY THE RPTR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE 18 LP LOW PROFILE BALLOON DILATATION CATHETER DQY CATHETER, PERCUTANEOUS DQY COOK, INC. NA 2671267

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention