BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLFLOW® IRRIGATION PUMP

    MDR report key: 6119290 · Received November 21, 2016

    Report

    Report Number
    1721752-2016-00012
    Event Type
    Injury
    Date Received
    November 21, 2016
    Date of Event
    October 28, 2016
    Report Date
    October 29, 2016
    Manufacturer
    HEI, INC.
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON JANUARY 20, 2017 STATING THAT AFTER THE OPERATION, THE PATIENT FELT WELL AND HAD NO COMPLAINTS. UPDATED PATIENT STATUS IS THAT HE FEELS WELL AND CONTINUES TO HAVE NO COMPLAINTS. MANUFACTURER'S REF. NO: (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. CONCOMITANT PRODUCT: COOLFLOW TUBING SET, MODEL #: D-1233-01-S, LOT #: UNKNOWN. NON-BIOSENSE WEBSTER, INC.: REPROCESSED CELSIUS THERMOCOOL (REPROCESSOR INFORMATION UNKNOWN). NON-BIOSENSE WEBSTER, INC.: ST. JUDE MEDICAL SWARTZ SHEATH. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PATIENT, (B)(6), FEMALE, UNDERWENT A PROCEDURE WITH A COOLFLOW PUMP. DURING THE PULMONARY VEIN ISOLATION, IT WAS NOT NOTICED THAT THE SALINE HAD FINISHED. THEREFORE, THE AIR RAN INTO THE COOLFLOW TUBING SET WHICH WAS CONNECTED TO THE REPROCESSED CELSIUS THERMOCOOL CATHETER. THE COOLFLOW PUMP DID NOT SHOW A BUBBLE ERROR. THE AIR ENTERED THE PATIENT'S CORONARY ARTERIES WHICH LED TO THE ST SEGMENT ELEVATION. AFTER THE SURGEON NOTICED ON THE X-RAY THAT THE AIR WAS IN THE CORONARY ARTERIES, HE INSERTED A SHEATH FOR CORONARY ARTERY CONTRAST ADMINISTRATION AND ASPIRATED THE AIR FROM THE CORONARY ARTERIES. THE AIR DID NOT GO TO THE BRAIN. THE PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION. THE PROCEDURE WAS PROLONGED BY 20 MINUTES AS A RESULT OF THE DIFFICULTIES ENCOUNTERED. THE SURGEON CONSIDERED THAT THE DELAY MAY CAUSE A SERIOUS INJURY THAT IS WHY HE ASPIRATED THE AIR AS SOON AS POSSIBLE. IT WAS NOTED THAT THERE WAS NO ISSUE WITH THE CATHETER. THE SURGEON MENTIONED THAT ALL THE TESTS BEFORE AND AFTER THE PROCEDURE WERE OKAY. THE PATIENT¿S DIAGNOSIS RELATED TO THIS EVENT WAS AN ST SEGMENT ELEVATION WITH SUBSEQUENT DEVELOPMENT OF HEART BLOCK AV THIRD DEGREE. REPAIR FOLLOW-UP WAS PERFORMED AND DEVICE WAS NOT SHIPPED FOR SERVICE. SERVICE WAS DECLINED. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. THE DEVICE HISTORY RECORD (DHR) REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, (B)(6), FEMALE, UNDERWENT A PROCEDURE WITH A COOLFLOW PUMP AND SUFFERED AN AIR EMBOLISM (WHICH REQUIRED ASPIRATION OF THE AIR FROM THE CORONARY ARTERIES), ST SEGMENT ELEVATION AND A HEART BLOCK AV THIRD DEGREE. THE PATIENT¿S MEDICAL HISTORY WAS UNKNOWN. DURING THE PULMONARY VEIN ISOLATION, IT WAS NOT NOTICED THAT THE SALINE HAD FINISHED. THEREFORE, THE AIR RAN INTO THE COOLFLOW TUBING SET WHICH WAS CONNECTED TO THE REPROCESSED CELSIUS THERMOCOOL CATHETER. THE COOLFLOW PUMP DID NOT SHOW A BUBBLE ERROR. THE AIR ENTERED THE PATIENT'S CORONARY ARTERIES WHICH LED TO THE ST SEGMENT ELEVATION. AFTER THE SURGEON NOTICED ON THE X-RAY THAT THE AIR WAS IN THE CORONARY ARTERIES, HE INSERTED A SHEATH FOR CORONARY ARTERY CONTRAST ADMINISTRATION AND ASPIRATED THE AIR FROM THE CORONARY ARTERIES. THE AIR DID NOT GO TO THE BRAIN. THE PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION. THE PROCEDURE WAS PROLONGED BY 20 MINUTES AS A RESULT OF THE DIFFICULTIES ENCOUNTERED. THE SURGEON CONSIDERED THAT THE DELAY MAY CAUSE A SERIOUS INJURY THAT IS WHY HE ASPIRATED THE AIR AS SOON AS POSSIBLE. IT WAS NOTED THAT THERE WAS NO ISSUE WITH THE CATHETER. THE SURGEON MENTIONED THAT ALL THE TESTS BEFORE AND AFTER THE PROCEDURE WERE OKAY. THE PATIENT¿S DIAGNOSIS RELATED TO THIS EVENT WAS AN ST SEGMENT ELEVATION WITH SUBSEQUENT DEVELOPMENT OF HEART BLOCK AV THIRD DEGREE. 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
    770093 COOLFLOW® IRRIGATION PUMP SIMILAR DEVICE CFP002, PMA # P990071/S5 LPB HEI, INC. M-5491-01

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening| R