BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIPHERAL CUTTING BALLOON

    MDR report key: 1082641 · Received July 23, 2008

    Report

    Report Number
    2134265-2008-02069
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 27, 2008
    Manufacturer
    BSC LETTERKENNY
    Product Code
    LIT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, BALLOON WITHDRAWAL DIFFICULTIES WERE ENCOUNTERED. A MALE PEDIATRIC PT WAS BORN WITH SEVERE CONGENITAL HEART DEFECTS FOLLOWING WHICH HAS UNDERGONE SURGERY TO CLOSE A HOLE IN HIS HEART INCLUDING IMPLANTING A SURGICAL CONDUIT TO IMPROVED THE CORONARY HEART FLOW. SINCE THIS TIME HE HAS GROWN BUT SOME VESSELS HAVE NOT GROWN WITH HIM AND NOW SHOW SEVERE NARROWING AND STENOSIS. IN THE LAST 12 MONTHS, THE PT HAS BEEN TREATED TWICE BY THE PHYSICIAN TO ATTEMPT TO IMPROVE THE FLOW THROUGH THE RIGHT PULMONARY ARTERY TO THE RIGHT LUNG BY STANDARD ANGIOPLASTY. EACH TIME, HE HAS REPRESENTED A SHORT TIME LATER WITH RECURRENT STENOSIS. SO AFTER DISCUSSION WITH THE SURGEONS, IT WAS AGREED TO ATTEMPT PTA AGAIN BUT THIS TIME WITH A PERIPHERAL CUTTING BALLOON (PCB). ACCESS WAS MADE THROUGH THE JUGULAR VEIN IN THE NECK BECAUSE IT WAS DECIDED THAT APPROACH FROM THE GROIN WOULD BE TOO TORTUOUS DUE TO OTHER STENOSED AND IRREGULAR VESSELS. SO TO ACCESS THE STENOSIS IN THE RIGHT PULMONARY ARTERY (RPA), A .014 OTHER MFR'S CARDIOLOGY WIRE AND 7F OTHER MFR'S SHEATH WAS ADVANCED THROUGH THE HEART WITH NO COMPLICATIONS. ONCE IN THE CORRECT POSITION, THE PERIPHERAL CUTTING BALLOON (PCB) WAS ADVANCED OVER THE WIRE, THROUGH THE SHEATH AND INTO POSITION IN THE RPA. INFLATION OF THE PCB WAS CARRIED OUT TWICE VIA HAND INJECTION WITH NO INFLATION DEVICE. A SLOW INFLATION AND DEFLATION OF APPROX 1 ATM PER 5 SECONDS WAS OBSERVED. AFTER EACH DEFLATION, EXTRA NEGATIVE PRESSURE WAS APPLIED TO ENSURE COMPLETE DEFLATION. AT THIS POINT, THE PROCEDURE WAS CONSIDERED SUCCESSFUL WITH IMPROVEMENT TO FLOW IN THE RPA NOTED ON ANGIOGRAPHY. AN ATTEMPT TO PULL THE PCB INTO THE LUMEN OF THE 7F OTHER MFR'S SHEATH WAS MADE. AT THIS POINT, RESISTANCE WAS NOTICED WITH DIFFICULTY IN GETTING THE PCB BACK INTO THE SHEATH. VARIOUS CATHETER MANIPULATIONS WERE TRIED, ADVANCING THE SHEATH FORWARDS WHILST PULLING THE PCB BACK. IT WAS FELT THAT DUE TO THE DIFFICULT ANATOMY OF THE VESSEL AND THE TIGHT BEND IN THE VESSEL STRUCTURE FROM WHERE THE COOK SHEATH WAS SITTING IN THE SURGICAL CONDUIT INTO THE RPA WHERE THE PCB WAS, THAT IT WAS CREATING THE SITUATION WHERE THE PCB WOULD NOT RE-ENTER THE SHEATH. IT SEEMED ON THE FLUOROSCOPY IMAGES THAT THE DEFLATED PCB WAS CATCHING ON THE OPEN LUMEN OF THE SHEATH DUE TO THE TIGHT BEND IN THE VESSEL. EVENTUALLY, AFTER LOTS OF MANIPULATION AND PULLING, THE SHEATH WAS REMOVED AND THE PCB WAS REMOVED FROM THE PT WITHOUT A SHEATH. THE PT DID NOT SUFFER ANY COMPLICATIONS BECAUSE OF THIS INCIDENT AND HAS RECOVERED WITHOUT ANY ADDITIONAL INTERVENTION. THE PCB WAS EXAMINED AFTER REMOVAL FROM THE PT AND THE PHYSICIAN IS CONFIDENT THAT NO PART OF THE PCB SUFFERED BREAKAGE OR WAS LEFT INSIDE THE PT. THIS WAS CONFIRMED BY BOTH CLOSE EXAMINATION OF THE PCB AND ALSO THROUGH SCREENING OF THE PT UNDER ANGIOGRAPHY. THE SHAFT OF THE PCB APPEARED TO HAVE STRETCHED SIGNIFICANTLY AFTER LOTS OF PULLING BY THE PHYSICIAN TO TRY AND GET IT TO ENTER THE SHEATH, BUT OTHER WISE NO BREAKAGE WAS NOTED. THE PHYSICIAN HAS STATED THAT HE FEELS THIS SITUATION DID NOT ARISE THROUGH PRODUCT FAILURE BUT DUE TO THE AWKWARD AND CHALLENGING ANATOMY OF THE PT'S VESSELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIPHERAL CUTTING BALLOON NA LIT BSC LETTERKENNY 5.00MM/2.0CM/135CM EH5707

    Patients

    Seq Age Sex Outcome Treatment
    1 COOK SHEATH| IRONMAN GUIDE WIRE