BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMILAR DEVICE S7001, PMA # P990071

    MDR report key: 6834897 · Received August 31, 2017

    Report

    Report Number
    9612355-2017-00100
    Event Type
    Malfunction
    Date Received
    August 31, 2017
    Date of Event
    August 2, 2017
    Report Date
    August 2, 2017
    Manufacturer
    STOCKERT GMBH
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON JULY 31, 2018. THE DEVICE HISTORY RECORD REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR VENTRICULAR TACHYCARDIA WITH A STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR AND A LOW TEMPERATURE ISSUE OCCURRED. THE DEVICE WAS EVALUATED AND NO ERROR WAS FOUND. DEVICE IS WITHIN SPECIFICATION. THE DEVICE WAS SUBJECTED TO PREVENTATIVE MAINTENANCE, SAFETY AND FUNCTIONAL TESTING AND ALL TESTS PASSED. NO MALFUNCTION FOUND ON DEVICE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. (B)(4) ARE RELATED TO THE SAME PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR VENTRICULAR TACHYCARDIA WITH A STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR AND A LOW TEMPERATURE ISSUE OCCURRED. AFTER ABLATING BRIEFLY WITH THE FIRST THERMOCOOL SMARTTOUCH UNIDIRECTIONAL SF CATHETER, THE TEMPERATURE DECREASED TO 4-6°C. PHYSICIAN STOPPED ABLATING TO TROUBLESHOOT. NO ERRORS DISPLAYED ON THE CARTO 3 SYSTEM. IT WAS ASSUMED THAT THE TEMPERATURE ISSUE WAS SECONDARY TO THE CATHETERS OR CABLES. SMARTTOUCH SF CATHETER AND CABLE WERE EXCHANGED AND THE ISSUE PERSISTED, AS THE GENERATOR CONTINUED TO REFLECT THE TEMPERATURE AS 6°C INSIDE AND OUTSIDE OF THE PATIENT¿S BODY. IT WAS THEN ASSUMED THAT THE GENERATOR WAS THE ISSUE. GENERATOR WAS REBOOTED SEVERAL TIMES, ENSURING THAT THE CORRECT TEMPLATE WAS CHOSEN. IT WAS NOTED THAT THE GENERATOR WAS RECENTLY SENT FOR PREVENTIVE MAINTENANCE AND AN UPGRADE FOR SF CATHETERS WAS ORDERED. IT WAS ASSUMED THAT THERE WAS AN ISSUE WITH THE UPGRADE. GENERATOR WAS RE-SET FOR A NON-SF CATHETER AND THE SECOND SMARTTOUCH SF CATHETER WAS EXCHANGED FOR A NON-SF CATHETER WHICH WAS INSERTED AND THE ISSUE PERSISTED. THE GENERATOR WAS SET ON POWER CONTROL MODE AT 30 WATTS AND TEMPERATURE CUT-OFF WAS 40°C. ABLATION WAS PERFORMED AT 30 WATTS. INITIALLY, THE TEMPERATURE WAS 20°C, WHICH RAPIDLY DECLINED TO 6-8°C, THEN REMAINED AT 6°C. IMPEDANCE WAS APPROXIMATELY 180-220 OHMS. IT WAS NOTED THAT THE SYSTEM ALLOWED ABLATION WHEN THE TEMPERATURE FELL TO 6-8°C, WHICH WAS BELOW THE CUTOFF VALUE. IT WAS ALSO CONFIRMED THAT THE GENERATOR DISPLAYED LESS THAN 10°C AND STILL ALLOWED ABLATION. THIS EVENT IS MDR REPORTABLE BECAUSE IF THE GENERATOR READS A LOWER TEMPERATURE THAN THE ALLOWED BASELINE TEMPERATURE FOR GENERATOR TO START THE ABLATION (10°C), AND STILL STARTS THE ABLATION, THIS COULD POTENTIALLY CAUSE PATIENT INJURY. IN ADDITION, DURING TROUBLESHOOTING, THE PATIENT DECOMPENSATED NEUROLOGICALLY AND A CVA WAS DIAGNOSED. REMAINDER OF PROCEDURE WAS ABORTED. STROKE UNIT SPECIALISTS AND NEUROLOGISTS ADMINISTERED UNSPECIFIED INTERVENTIONS. AFTER STABILIZATION, PATIENT WAS TRANSFERRED TO THE STROKE UNIT. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT FOR TREATMENT. A FEW DAYS POST-PROCEDURE, MOTOR DEFICIT HAD IMPROVED, BUT UNILATERAL FACIAL PARALYSIS PERSISTED. MOST RECENT STATUS UPDATE INDICATED THAT THE PATIENT OUTCOME WAS IMPROVED. PHYSICIAN PRESUMED THAT AFTER INSERTING AND REMOVING THE CATHETERS RETROGRADE VIA THE AORTA INTO THE LEFT VENTRICLE, A THROMBUS WAS RELEASE BY A CATHETER. PHYSICIAN INDICATED THAT THERE WERE NO PRODUCT DEFECTS. CATHETER TIPS WERE EVALUATED AND NO CHAR WAS OBSERVED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT WAS THAT IT WAS RELATED TO PROCEDURE AND PATIENT CONDITION. THE CVA WAS ATTRIBUTED TO THE CATHETERS USED. THE ADVERSE EVENT WAS REPORTED SEPARATELY TO THE FDA UNDER THE FOLLOWING REPORT NUMBERS: 9673241-2017-01016, 9673241-2017-01017 AND 9673241-2017-01018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616586 SIMILAR DEVICE S7001, PMA # P990071 LPB STOCKERT GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1