BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPLEGE CORONARY SINUS DEVICE

    MDR report key: 2962519 · Received February 14, 2013

    Report

    Report Number
    3008500478-2013-00393
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 29, 2013
    Report Date
    April 30, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    5120780
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE CATHETER WAS VISUALLY INSPECTED AND NO VISUAL DEFECTS WERE FOUND. A FUNCTIONAL ARTICULATION TEST WAS PERFORMED BY ACTUATING THE THUMB SWITCH AND FOUND THAT THE TIP ARTICULATES AS NORMAL WHEN THE THUMB SWITCH IS MOVED THROUGH ITS VARIOUS POSITIONS. THE REPORT DOES NOT IMPLICATE ANY ALLEGED DEFECTS WITH THE PROPLEGE DEVICE; PERFORATIONS OF THE CORONARY SINUS CAN BE DUE TO USER ERROR OR ANATOMY OF THE PATIENT. THE REPORT NOTES THAT WHEN UNDERGOING REPAIR, THE PATIENT HAD A FRIABLE SINUS, WHICH MAY HAVE CONTRIBUTED TO THE DISSECTION. SINCE THE RETURNED DEVICE WAS NOT DEFECTIVE, IT IS MOST LIKELY THAT THE ROOT CAUSE(S) OF THE COMPLICATIONS REPORTED ARE APPLICATION BASED; HOWEVER, THE ROOT CAUSE IS INDETERMINABLE. NO DEVICE MALFUNCTION IS INDICTED IN THE REPORT AND THE EVENTS REPORTED ARE INCLUDED IN THE LABELING. NO ACTIONS ARE NEEDED AT THIS TIME. NO CAPA REQUIRED AT THIS TIME PER ASSESSMENT. THE INFORMATION GATHERED DURING THIS REPORTED EVENT AND EVALUATION WILL ALSO BE INCLUDED IN TRENDING DATA FOR FUTURE CAPA DETERMINATIONS. TRENDS WILL CONTINUE TO BE MONITORED ON A MONTHLY BASIS AND IF FURTHER ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED UPON PRODUCT RETURN FROM THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS VISUALLY INSPECTED AND NO VISUAL DEFECTS WERE FOUND. THE REPORT DOES NOT IMPLICATE ANY ALLEGED DEFECTS WITH THE PROPLEGE DEVICE; PERFORATIONS OF THE CORONARY SINUS CAN BE DUE TO USE ERROR OR ANATOMY OF THE PATIENT. THE REPORT NOTES THAT WHEN UNDERGOING REPAIR, THE PATIENT HAD A FRIABLE SINUS, WHICH MAY HAVE CONTRIBUTED TO THE DISSECTION. SINCE THE RETURNED DEVICE WAS NOT DEFECTIVE, IT IS POSSIBLE THAT THE ROOT CAUSE(S) OF THE COMPLICATIONS REPORTED ARE APPLICATION BASED; HOWEVER, THE ROOT CAUSE IS UNABLE TO BE CONFIRMED. THE DEVICE AS RETURNED MEETS ALL OF THE FINAL ACCEPTANCE CRITERIA. NO CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. THE LOT NUMBER OF THE DEVICE IN QUESTION IS UNKNOWN; THEREFORE, A LHR CANNOT BE CONDUCTED. RELATING TO THE ADVERSE PATIENT EVENT: THE CATHETER WAS VISUALLY INSPECTED AND NO VISUAL DEFECTS WERE FOUND. THE INSTRUCTIONS FOR USE GIVE GUIDANCE AROUND DEVICE PLACEMENT AS: ¿ONCE THE PROPLEGE DEVICE CAN BE SEEN IN THE RIGHT ATRIUM, ADVANCE GENTLY WHILE APPLYING COUNTER CLOCKWISE TORQUE TO ALIGN THE CURVE OF THE DEVICE WITH THE INTRA-ATRIAL SEPTUM TO PLACE THE PROPLEGE DEVICE TIP AT THE OSTIUM OF THE CORONARY SINUS. ¿ THERE IS ALSO WARNINGS REGARDING POSITIONING AND INJURIES THAT MAY OCCUR WITH THE USE OF THE DEVICE, IN THAT ¿ IF RESISTANCE IS MET, STOP AND RE-EVALUATE PROPLEGE DEVICE POSITION. THE PROPLEGE DEVICE SHOULD NOT BE ADVANCED IF RESISTANCE IS FELT, AS DOING SO WOULD CAUSE THE PROPLEGE DEVICE TO BEND OR BUCKLE. AGGRESSIVE ADVANCEMENT IN AN ATTEMPT TO ENGAGE THE OSTIUM MAY RESULT IN PERFORATION OR OTHER INJURY.¿ ¿ONCE PLACED IN THE BODY, THE PROPLEGE DEVICE SHOULD BE MANIPULATED ONLY WHILE BEING OBSERVED USING FLUOROSCOPY AND/OR TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND WHILE MONITORING PRESSURE AT THE PROPLEGE DEVICE TIP.¿ ¿WARNING: AGGRESSIVE ADVANCEMENT OF THE GUIDEWIRE IN AN ATTEMPT TO ENGAGE THE OSTIUM MAY RESULT IN PERFORATION OR OTHER INJURY.¿ ¿ WARNING: OVERINFLATION MAY RESULT IN INJURY TO THE CORONARY SINUS. IF THE PATIENT BECOMES HEMODYNAMICALLY UNSTABLE, THE POSSIBILITY OF PERICARDIAL TAMPONADE MAY BE ASSESSED WITH APPROPRIATE TEE VIEWS.¿ IN THE REPORTED COMPLAINT THERE IS NO ALLEGATION THAT THE SURGEON DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IT IS PERCEIVED THAT THE PHYSICIAN DID AS INSTRUCTED BY THE IFU. IN THE TRAINING MATERIALS THERE IS SPECIFIC GUIDANCE TO IMAGING IN REGARDS TO NAVIGATING THE ANATOMY TO PREVENT INJURIES. IT ALSO ADDRESSES PLACEMENT TO SAFELY NAVIGATE THE VESSEL, ¿HOWEVER, THE DEVICE HAS TAKEN AN INCORRECT TRACK AND IS NOT IN THE CORONARY SINUS. INSTEAD, AS MARKED BY THE SOLID, SMALLER ARROW THE DEVICE TIP IS IN THE MIDDLE CARDIAC VEIN, THE MOST COMMONLY CANNULATED SIDE BRANCH. WHEN THE PROPLEGE DEVICE IS IN THE MIDDLE CARDIAC VEIN, DO NOT INFLATE THE BALLOON OR CONTINUE ADVANCEMENT AS THESE ACTIONS COULD POTENTIALLY LEAD TO VESSEL INJURY. ¿ THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. REVIEW OF THE AVAILABLE INFORMATION INDICATES THAT THE EVENT REPORTED WAS NOT RELATED TO A MALFUNCTION OF THE PROPLEGE AND RELATED ONLY TO AN ADVERSE EVENT. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT A PATIENT EXPERIENCED A CORONARY SINUS DISSECTION AFTER THE 3RD DOSE OF RETROGRADE AT THE END OF THE PROCEDURE WITH THE PROPLEGE CORONARY SINUS DEVICE. THE CASE WAS CONVERTED TO AN OPEN STERNOTOMY AND THE REPAIR WAS MADE. THE REPAIR WAS DIFFICULT DUE TO THE "FRIABLE" SINUS. THE PT IS STATED TO BE DOING WELL. THE PT WAS (B)(6) MALE. PLACEMENT WAS DONE UNDER TEE AND FLUORO PER IFU INSTRUCTIONS. THE BALLOON INFLATION WAS WITHIN NORMAL LIMITS PER ANESTHESIA. LINE PRESSURES WERE NORMAL. NO ADDITIONAL VOLUME WAS ADDED TO THE BALLOON AFTER INSERTION (INFLATION WAS 0.6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65321 PROPLEGE CORONARY SINUS DEVICE CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES PR9

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR