BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMPIRA NC RX PTCA DILATATION CATHETER

    MDR report key: 3496307 · Received November 8, 2013

    Report

    Report Number
    3004036480-2013-00011
    Event Type
    Injury
    Date Received
    November 8, 2013
    Date of Event
    September 25, 2013
    Report Date
    September 30, 2013
    Manufacturer
    CREGANNA MEDICAL
    Product Code
    LOX
    PMA / PMN Number
    K110133
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER:75R15300N, LOT NUMBER: CE0002000, EMPIRA NC RX PTCA 15 X 3.00; MODEL NUMBER:75R10300N, LOT NUMBER: CE0001719, EMPIRA NC RX PTCA 10 X 3.00. ANALYSIS AND OBSERVATIONS - RETURN 5129-1 (LOT NO. CE0002000): - THE PRODUCT RETURNED WAS AN EMPIRA NC 3.5 X 10MM BALLOON CATHETER. AS PER THE DESCRIPTION IN THE COMPLAINT REPORT, THE PRODUCT WAS RETURNED IN A PARTIAL CONDITION WITH THE TIP, BALLOON & INNER SHAFT ABSENT FROM THE CATHETER ASSEMBLY . OBSERVATION OF THE PARTIAL ASSEMBLY SUGGESTS THAT THE REMAINING PRODUCT IS IN GENERALLY GOOD CONDITION AND IS FREE OF SIGNIFICANT KINKS OR ANOMALIES AND CONFORMS TO MANUFACTURING STANDARD. THE DISTAL END OF THE OUTER SHAFT (DETACHMENT SITE OF THE BALLOON) CAN BE SEEN TO HAVE FLARED OR EXPANDED FROM ITS NORMAL STATE . THE INNER SHAFT APPEARS TO HAVE DETACHED AT THE RX JOINT. FINDINGS: - THE CATHETER HAS BEEN RETURNED IN AN INCOMPLETE THE CONDITION. MISSING ARE THE CATHETERS BALLOON, SOFT TIP, INNER SHAFT & RO BANDS. - THE PROXIMAL SHAFT ASSEMBLY, INTERMEDIATE SHAFT, INTERMEDIATE & RX JOINTS AND THE PROXIMAL END OF THE OUTER SHAFT APPEAR IN GOOD CONDITION AND REFLECT MANUFACTURING STANDARD. - THE OUTER SHAFT HAS FRACTURED AT APPROXIMATELY 21.5CM FROM THE RX PORT. THIS INDICATES THAT THE FRACTURE SITE IS DIRECTLY PROXIMA L TO THE BALLOONS PROXIMAL BOND. - THE FRACTURE SITE DISPLAYS WHAT APPEARS TO BE A THIN FILM FAILURE, WHERE THE SHAFT HAS EXPANDED IN DIAMETER AND THE WALL HAS THINNED OUT AS A RESULT. CONCLUSIONS: - OBSERVATIONS SUGGEST THAT THE PRIMARY CAUSE OF FAILURE IS DUE TO SHAFT DAMAGE, PROXIMAL TO THE BALLOONS PROXIMAL BOND. THE DISTAL OUTER SHAFT DISPLAYS A THIN FILM EXPANDED FAILURE AT THE FRACTURE SITE, CONSISTENT WITH A PRESSURE EXPANSION OF THE TUBING. - WITH A SIGNIFICANT PORTION OF THE CATHETER MISSING, IT IS ONLY POSSIBLE TO SPECULATE WITH RESPECT TO THE FAILURE MODE. THIS DAMAGE IS LIKELY TO HAVE OCCURRED DURING THE REMOVAL OF THE BALLOON PROTECTOR WHERE THE OUTER SHAFT HAS YIELDED AS A RESULT OF THE TENSILE FORCE APPLIED TO REMOVE THE SHEATH. ONCE PRESSURE HAS BEEN APPLIED TO THE CATHETER THE SHAFT HAS EXPANDED LOCALLY AT THE SHAFT DAMAGE SITE. THE THIN FILM HAS BURST RESULTING IN A PRESSURE LOSS IN THE DEVICE. ONCE THE PRESSURE HAS BEEN LOST IT IS LIKELY THAT THE PROCEDURE HAS BEEN TERMINATED AND THE DEVICE HAS BEEN RETRIEVED FROM THE ANATOMY. THE TENSILE FORCE TO RETRIEVE THE CATHETER MAY HAVE RESULTED IN A TEARING OF THE THIN FILM AT THE FAILURE SITE AND A SEPARATION OF THE OUTER SHAFT FROM THE DISTAL BALLOON ASSEMBLY. IN THIS SCENARIO THE INNER SHAFT WOULD BE SUBJECT TO THE TENSILE REMOVAL FORCE, WHERE IT SUBSEQUENTLY DETACHED AT THE RX JOINT. THE ISSUE OF PROTECTOR REMOVAL FORCES REMAINS PART OF AN ON-GOING INVESTIGATION. ANALYSIS & OBSERVATIONS- RETURN 5129-2 (LOT NO. CE0001719): THE PRODUCT RETURNED WAS AN EMPIRA NC 3.0 X 10MM BALLOON CATHETER. OBSERVATION OF THE RETURNED CATHETER ASSEMBLY SHOWS THAT THE PRODUCT DISPLAYS SHAFT KINKS CONSISTENT WITH ROBUST USE AND OR ISSUES OF RETURN HANDLING. A WHITE POWDERY RESIDUE IS OBSERVED IN THE INFLATION LUMEN AREA OF THE CATHETERS DISTAL SHAFTS & INSIDE THE BALLOON. THE BALLOON SHOWS AN APPROXIMATE TRI-FOLD PROFILE. THE POLYMER OUTER SHAFT NO LONGER APPEARS ROUND IN SEVERAL AREAS ALONG IT LENGTH. THERE ARE NO OTHER OBVIOUS SIGNS OF MECHANICAL DAMAGE UPON THE DEVICE. FINDINGS: - THE CATHETER HAS BEEN RETURNED IN USED (INFLATED) CONDITION. THE STYLETTE & BALLOON PROTECTOR ARE ABSENT. THE MAJOR BONDS CONFORM TO MANUFACTURING STANDARD. - THE CATHETERS DISTAL POLYMER ASSEMBLY DISPLAYS A WHITE RESIDUE INSIDE ITS FLUID LUMEN. THIS SUBSTANCE HAS DRIED OUT LEAVING A POWDERY SUBSTANCE THAT IS NOW PREVENTING PRESSURISATION OF THE CATHETERS DISTAL ASSEMBLY. - THE CATHETERS DISTAL SHAFTS ARE NO LONGER CIRCULAR IN DIAMETER. THE SHAFTS ARE NOW FLATTENED & DISPLAY A TWISTED APPEARANCE. THERE ARE ALSO SEVERAL MINOR KINKS EVIDENT. THE SHAFTS APPEAR TO HAVE WITHSTOOD A RADIALLY COMPRESSIVE FORCE THAT HAS CAUSED THIS SHAFT DISTORTION. - THE POWDER CONTAMINANT BLOCKS THE INFLATION LUMEN TO THE DISTAL END OF THE POLYMER SHAFT. IT IS NOT POSSIBLE TO TEST THE BALLOON FOR INFLATION. VISUAL INSPECTION SUGGESTS THAT THE BALLOON AND ITS ASSOCIATED BONDS REMAIN INTACT. CONCLUSIONS: THE CATHETER DISPLAYS A WHITE RESIDUE WHICH APPEARS TO BE A COMPACTED POWDER IN THE INFLATION LUMEN, DISTALLY FROM THE RX JOINT. IT IS SPECULATED THAT THIS MAY BE A CLEANING AGENT AS PART OF EITHER PRIOR EVALUATION OR THE DECONTAMINATION PROCESS (SPECULATION THAT THIS MAY HAVE OCCURRED IF THE FLUID WAS NOT EVACUATED FROM THE CATHETER & PERMITTED TO DRY). AS A CONSEQUENCE IT IS NOT POSSIBLE TO FUNCT IONALLY APPRAISE THE CATHETER THROUGH STANDARD INFLATION MEANS. ANOTHER ANOMALY IS THE DISTORTION OF THE CATHETERS DISTAL SHAFTS, WITH THE OUTER SHAFT NO LONGER CIRCULAR IN PROFILE ALONG ITS LENGTH. THE DISTAL SHAFTS APPEAR TO BE COMPRESSED RADIALLY BETWEEN THE RX PORT AND THE BALLOON. AS THE CATHETER IS SUPPLIED IN A PROTECTIVE SHIPPING HOOP IT LIKELY THAT THIS DISTORTION HAS OCCURRED POST PROCEDURE AND IS POSSIBLY A CONSEQUENCE OF RETURN HANDLING. THE REPORTED COMPLAINT WAS "THE SLEEVE OF THE SECOND BALLOON WAS VERY TIGHT AND THEY WERE UNABLE TO REMOVE THE SLEEVE". AT THIS TIME, IT IS NOT KNOWN IF THE SHAFT COMPRESSION I DISTORTION OCCURRED DURING ATTEMPTS TO REMOVE THE BALLOON PROTECTOR OR IF THEY OCCURRED DURING RETURN HANDLING. WITH THE PROTECTOR DETACHED I DISCARDED AND THE BALLOON SHOWING SIGNS OF INFLATION IT IS NOT POSSIBLE TO QUANTIFY REMOVAL FORCES OR CONFIRM THE COMPLAINT IN THIS CASE. IT IS HOWEVER THOUGHT THAT THE CONTAMINANT CAUSING BLOCKAGE IN THE SHAFT IS A FUNCTION OF THE RETURN DECONTAMINATION PROCESS AND NOT PART OF THE INITIAL COMPLAINT.

    Description of Event or Problem · 1

    THE PROCEDURE WAS PTCA WITH ONE DRUG ELUTING STENT TO LAD PROXIMAL SVG GRAFT. WIRED WITH FLOPPY WIRE AND PRE-DILATED WITH SEMI COMPLIANT BALLOON AND STENTED. AFTER STENTING, POST DILATED WITH EMPIRA NC BALLOON. DURING POST DILATATION, THE SHAFT AND THE BALLOON PART BROKEN AND OCCLUDED THE SGV GRAFT. THE DOCTOR TRIED TO GET THE BROKEN BALLOON PART BACK BUT WAS NOT SUCCESSFUL. THE ANGIOGRAM SHOWED NO FLOW AND THE PT HAS BEEN TAKEN TO THE EMERGENCY SURGERY.

    Description of Event or Problem · 1

    DURING USE OF AN EMPIRA NC 3.5/10 BALLOON IT WAS REPORTED THAT THE BALLOON RUPTURED AND DURING REMOVAL HE WAS UNABLE TO TAKE BACK THE RUPTURED BALLOON THROUGH THE GUIDING CATHETER (GUIDE CATHETER MEDTRONIC 7F EBU 3.5). THE PATIENT WAS SENT FOR CABG. THE PATIENT IS A (B)(6) MALE. THE PROCEDURE WAS A PERCUTANEOUS CORONARY ANGIOPLASTY WITH STENTING. THE PRODUCTS WERE PROPERLY INSPECTED AND PREPPED. ONE DRUG ELUTING (3×28 PROMUS ELEMENT) STENT WAS PLACED IN THE LEFT ANTERIOR DESCENDING (LAD) PROXIMAL SVG GRAFT. THE LESION WAS WIRED WITH A FLOPPY WIRE AND PRE-DILATED WITH A SEMI COMPLIANT BALLOON AND STENTED. AFTER STENTING, POST DILATION WITH THE EMPIRA NC BALLOON WAS PERFORMED. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON THROUGH THE SHEATH. THE BALLOON CATHETER DID NOT KINK OR BEND DURING ADVANCEMENT. THERE WAS NO EXCESSIVE FORCE USED TO CROSS THE STENTED LESION WITH THE BALLOON. DURING POST DILATATION, THE BALLOON RUPTURED AT 16 ATMOSPHERES DURING ITS SECOND INFLATION. THE BALLOON WAS INFLATED FOR 30 SECONDS. AN ENCORE INFLATION DEVICE WAS USED TO INFLATE THE BALLOON. TELEBRIX INFLATION MEDIUM WAS USED WITH A CONTRAST TO SALINE RATIO OF 1:4. WHEN THE PHYSICIAN TRIED GETTING THE BALLOON BACK, THE SHAFT BROKE AND PART OF THE BALLOON WAS INSIDE THE STENTED SEGMENT. THE PHYSICIAN TRIED WITH A SNARE TO GET THE BALLOON PART BACK BUT WAS NOT SUCCESSFUL. AN ANGIOGRAM SHOWED NO FLOW AND THE PATIENT HAS BEEN TAKEN FOR EMERGENCY SURGERY. AFTER SURGERY THE PATIENT IS DOING FINE. ALSO DURING THE PROCEDURE AN EMPIRA 10 X 3.00 BALLOON WAS OPENED BUT NOT USED AS THE PHYSICIAN WAS UNABLE TO REMOVE THE SLEEVE OF THE BALLOON AS IT WAS VERY TIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578480 EMPIRA NC RX PTCA DILATATION CATHETER PTCA CATHETER LOX CREGANNA MEDICAL 75R10300N CE0001719

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R