BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLFLOW® IRRIGATION PUMP

    MDR report key: 6146604 · Received December 5, 2016

    Report

    Report Number
    1721752-2016-00013
    Event Type
    Injury
    Date Received
    December 5, 2016
    Date of Event
    November 9, 2016
    Report Date
    November 9, 2016
    Manufacturer
    HEI, INC.
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO SERIAL NUMBER WAS PROVIDED BY THE CUSTOMER. SMART TOUCH BIDIRECTIONAL CATHETER, MODEL #: D-1327-05-S, LOT #: 17532049M; CARTO 3 SYSTEM, MODEL #:M-4800-01, SERIAL #: (B)(4); C3 EZ STEER CORONARY SINUS WITH AUTO ID CATHETER, MODEL: D-1263-06-S, LOT #: 17563968M; NON BIOSENSE WEBSTER, INC.- JOSEPHSON QUAD CATHETER, F6QA005RT / LOT #: 17575196M. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT ATRIAL TACHYCARDIA ABLATION PROCEDURE WITH A COOLFLOW PUMP AND SUFFERED PULMONARY EDEMA REQUIRING NO MEDICAL OR SURGICAL INTERVENTION. DURING THE PROCEDURE, FLASH PULMONARY EDEMA OCCURRED. INJURY HAS NOT BEEN CONFIRMED. THERE IS NO INFORMATION REGARDING HOW THE INJURY WAS DISCOVERED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE TIME THE COMPLAINT WAS REPORTED. THERE IS NO INFORMATION ABOUT THE HOSPITALIZATION. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION 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 MIGHT RESULT IN 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
    797311 COOLFLOW® IRRIGATION PUMP SIMILAR DEVICE CFP002, PMA # P990071/S5 LPB HEI, INC. M-5491-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other