BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 5988803 · Received September 29, 2016

    Report

    Report Number
    9673241-2016-00629
    Event Type
    Injury
    Date Received
    September 29, 2016
    Date of Event
    September 6, 2016
    Report Date
    September 9, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A PEER REVIEW ON SEPTEMBER 30, 2016, IT WAS NOTED THAT WE REPORTED THE FOLLOWING: THE PATIENT SUFFERED A PERICARDIAL EFFUSION WHICH REQUIRED HEPARIN AND EXTENDED HOSPITALIZATION. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE. IT SHOULD HAVE STATED THAT THE PATIENT SUFFERED A PERICARDIAL EFFUSION WHICH REQUIRED EXTENDED HOSPITALIZATION. IT WAS ALSO REPORTED THAT ONE DAY POST-PROCEDURE, THE PATIENT HAD A VERY LOW ACTIVATED CLOTTING TIME, WHICH REQUIRED A HEPARIN INJECTION. SINCE THIS ADVERSE EVENT REQUIRED EXTENDED HOSPITALIZATION, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE. OUTCOMES ATTRIBUTED TO ADVERSE EVENT (REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES)) WAS CHECKED. IT SHOULD HAVE NOT BEEN CHECKED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL SMARTTOUCH APPROVED UNDER P030031/S053. CONCOMITANT PRODUCTS: PENTARAY NAVIGATIONAL ECO CATHETER, MODEL #: D-1282-11-S, LOT #: UNKNOWN; LASSO VARIABLE CATHETER, MODEL #: D-1237-02-S, LOT #: UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    ORIGINALLY, WE REPORTED THAT THE DEVICE IN THE 3500A INITIAL REPORT WAS NOT APPROVED BY THE FDA. HOWEVER, BIOSENSE WEBSTER INC. CONSIDERED IT A SIMILAR DEVICE AND WAS REPORTING THE EVENT. THIS SUPPLEMENTAL IS A CORRECTION AS THE PRODUCT WAS FDA APPROVED. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CAN NOT BE PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) WITH A SMART TOUCH BIDIRECTIONAL SF CATHETER AND SUFFERED A PERICARDIAL EFFUSION WHICH REQUIRED HEPARIN AND EXTENDED HOSPITALIZATION. THE PATIENT'S MEDICAL HISTORY IS UNKNOWN. THERE WAS A POST-OPERATIONAL PERICARDIAL EFFUSION OBSERVED ON THE PATIENT. THE PHYSICIAN COULD NOT IDENTIFY WHEN THE PERICARDIAL EFFUSION OCCURRED. THIS ISSUE LED TO THE PATIENT REQUIRING EXTENDED HOSPITALIZATION. IT WAS NOTED THAT THE DAY AFTER THE PROCEDURE THERE WAS A PROBLEM WITH THE ACT SYSTEM. THE PATIENT HAD A VERY LOW ACT AND IT WAS NECESSARY TO INJECT AN IMPORTANT DOSE OF HEPARIN. THE PATIENT WAS REPORTED TO BE FINE AT THE TIME THE COMPLAINT WAS REPORTED. THE PHYSICIAN DID NOT KNOW THE REASON FOR THE CAUSE OF THIS ADVERSE EVENT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639792 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-04-S UNKNOWN_D-1348-04-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R