BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 7288667 · Received February 22, 2018

    Report

    Report Number
    2210968-2018-70983
    Event Type
    Injury
    Date Received
    February 22, 2018
    Report Date
    February 14, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    PMA / PMN Number
    CL I EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 9/9/2020.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. IS THERE AN ALLEGED DEFICIENCY AGAINST THE BLAKE DRAINS USED DURING THE PATIENT¿S PROCEDURE? DOES THE PI BELIEVE THERE WAS A DECREASE IN PERFORMANCE OF THE BLAKE DRAIN? IF SO, PLEASE ELABORATE. CITATION: SURG TODAY. 2008; 38:283¿284. DOI: 10.1007/S00595-007-3602-9.

    Additional Manufacturer Narrative · 1

    PC-000127380 ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: IS THERE AN ALLEGED DEFICIENCY AGAINST THE BLAKE DRAINS USED DURING THE PATIENT¿S PROCEDURE? DOES THE PI BELIEVE THERE WAS A DECREASE IN PERFORMANCE OF THE BLAKE DRAIN? IF SO, PLEASE ELABORATE. - THERE WAS NO DRAIN DEFICIENCY

    Description of Event or Problem · 1

    LITERATURE ARTICLE: CARDIOGENIC SHOCK FROM CORONARY COMPRESSION: A DIFFICULT DIAGNOSIS BUT EASY FIX MEDIASTINAL DRAINS ARE ROUTINELY PLACED TO PREVENT FLUID ACCUMULATION AFTER CARDIAC SURGERY. VARIOUS COMPLICATIONS HAVE BEEN ASSOCIATED WITH CLOSED INSERTION OF PLEURAL DRAINS; HOWEVER, REPORTS OF COMPLICATIONS FROM OPEN, INTRAOPERATIVE MEDIASTINAL DRAIN PLACEMENT ARE LESS COMMON. THIS CASE REPORT CONCERNS A (B)(5) WOMAN WITH RHEUMATIC HEART DISEASE AND SEVERE MITRAL VALVE STENOSIS. OTHER SYMPTOMS INCLUDED DYSPNEA ON EXERTION AND LOWER EXTREMITY EDEMA. HER TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) DEMONSTRATED A TRANSVALVULAR GRADIENT OF 14 MMHG AND SEVERE LEFT ATRIAL ENLARGEMENT WITH LEFT APPENDAGE THROMBUS. THE PATIENT UNDERWENT A MITRAL VALVE REPLACEMENT, A LEFT-SIDED CRYO-MAZE PROCEDURE, AND LEFT ATRIAL APPENDAGE CLOSURE. POST OPERATIVELY, THE PATIENT EXHIBITED PROGRESSIVE CARDIOGENIC SHOCK WITH A FALL IN HER MIXED VENOUS OXYGEN SATURATION FROM 75% TO 46% AND AN INCREASING VASOPRESSOR AND INOTROPIC AGENT REQUIREMENT. HER ELECTROCARDIOGRAM SHOWED DEMONSTRATED T-WAVE INVERSIONS IN THE ANTEROLATERAL LEADS AND REPEAT TEE SHOWED SEVERE LEFT VENTRICULAR DYSFUNCTION WITH APICAL AKINESIS. THE PATIENT¿S CORONARY ANGIOGRAPHY REVEALED LIMITED FLOW IN THE NATIVE LEFT ANTERIOR DESCENDING CORONARY ARTERY DISTAL TO THE BLAKE FR 19 DRAIN. THE SURGEONS IMMEDIATELY REMOVED THE DRAIN AND THE FLOW RESTORED. SUBSEQUENTLY, HER HEMODYNAMIC STATUS RAPIDLY IMPROVED, AND SHE WAS WEANED OFF INOTROPIC AND VASOPRESSOR SUPPORT. IT WAS REPORTED THAT COMPLICATIONS AFTER CLOSED INSERTION OF PLEURAL CHEST TUBES ARE WIDELY RECOGNIZED AND REPORTED, RANGING FROM SERIOUS ORGAN INJURIES TO BENIGN PNEUMOTHORAX. HOWEVER, REPORTS OF COMPLICATIONS FROM AN OPEN MEDIASTINAL DRAIN PLACEMENT ARE RARE PERHAPS BECAUSE MOST COMPLICATIONS ARE BENIGN AND EASILY MANAGED. YET, SERIOUS COMPLICATIONS ARE POSSIBLE. IT WAS CONCLUDED THAT THE CASE REPORTED HIGHLIGHTS THE POTENTIALLY SERIOUS COMPLICATIONS THAT CAN RESULT FROM A ROUTINE STEP IN CARDIAC SURGERY AND REINFORCE THE NEED FOR RAPID ANGIOGRAPHIC CORONARY EVALUATION IN CASES OF SUSPECTED MYOCARDIAL ISCHEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132760 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention