BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DLP SILICONE RCSP RETROGRADE RETROGRADE RETROGRADE CANNULA

    MDR report key: 10975598 · Received December 9, 2020

    Report

    Report Number
    2184009-2020-00083
    Event Type
    Injury
    Date Received
    December 9, 2020
    Date of Event
    August 1, 2000
    Report Date
    February 10, 2021
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DWF
    PMA / PMN Number
    K860149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC INVESTIGATION: MEDTRONIC CANNOT CONFIRM OR DENY THE COMPLAINT OF CARDIAC CONTUSION AS NO PRODUCT HAS BEEN RETURNED TO DATE. A ROOT CAUSE OF THIS OCCURRENCE CANNOT BE DETERMINED WITHOUT RETURNED PRODUCT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS NO LOT NUMBER WAS PROVIDED. COMPLAINTS RECEIVED FOR SIMILAR MODEL NUMBERS WERE REVIEWED AND SHOWED NO TRENDS WARRANTING ESCALATION RELATED TO THIS OCCURRENCE. THIS INVESTIGATION WAS COMPLETED WITH THE INFORMATION THAT WAS PROVIDED, IF ADDITIONAL INFORMATION IS RECEIVED, THIS INVESTIGATION WILL BE REOPENED IF DEEMED NECESSARY. IF THE PRODUCT IS RETURNED, THIS COMPLAINT WILL BE REOPENED AND THE ANALYSIS AND INVESTIGATION WILL BE UPDATED. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THIS OCCURRENCE. MEDTRONIC HAS MADE ITS SUPPLIER AWARE OF THIS OCCURRENCE AND WILL CONTINUE TO MONITOR FOR FUTURE OCCURRENCES AND TRENDS. LITERATURE ARTICLE: 'IATEROGENIC INJURIES DURING RETROGRADE DELIVERY OF CARDIOPLEGIA.' T.K. KAUL, B.L. FIELDS AND C.R. JONES DEPARTMENT OF CARDIAC SURGERY, BAPTIST MEDICAL CENTER, 817 PRINCETON AVENUE SW, BIRMINGHAM, AL 35211, USA CARDIOVASCULAR SURGERY, VOL. 8, NO. 5, PP. 400¿403, 2000 2000 THE INTERNATIONAL SOCIETY FOR CARDIOVASCULAR SURGERY. PUBLISHED BY ELSEVIER SCIENCE LTD S0967-2109(00)00029-6. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE: 'IATEROGENIC INJURIES DURING RETROGRADE DELIVERY OF CARDIOPLEGIA.' T.K. KAUL, B.L. FIELDS AND C.R. JONES DEPARTMENT OF CARDIAC SURGERY, BAPTIST MEDICAL CENTER, 817 PRINCETON AVENUE SW, BIRMINGHAM, AL 35211, USA CARDIOVASCULAR SURGERY, VOL. 8, NO. 5, PP. 400¿403, 2000 2000 THE INTERNATIONAL SOCIETY FOR CARDIOVASCULAR SURGERY. PUBLISHED BY ELSEVIER SCIENCE LTD S0967-2109(00)00029-6. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING IATEROGENIC INJURIES DURING RETROGRADE DELIVERY OF CARDIOPLEGIA ALL DATA WERE COLLECTED FROM A SINGLE CENTER OVER EIGHT YEARS. THE STUDY POPULATION INCLUDED 3 PATIENTS WHERE RETROGRADE DELIVERY OF CARDIOPLEGIA WAS USED UTILIZING A DLP INC (GRAND RAPIDS, MI). CASE 4: AMONG ALL PATIENTS, 1 CARDIAC CONTUSION FROM INJURIES TO MARGINAL CARDIAC VEINS WITHOUT EXTERNAL HAEMORRHAGE OCCURRED. BASED ON THE AVAILABLE INFORMATION, THIS ADVERSE AFFECT MAY HAVE BEEN ATTRIBUTED TO MEDTRONIC PRODUCT. PATIENT UNDERWENT QUADRUPLE CABG PROCEDURE. CATHETER WAS ADVANCED TOO FAR AND INJURIES WERE CAUSED EITHER FROM CATHETER TIP WITH STYLETTE IN SITU, OR DURING CARDIOPLEGIC INFUSION FROM A SMALL BURST DUE TO HIGH RESISTANCE. IN ORDER TO AVOID DELAYED RUPTURE AND BLEEDING, CARDIAC CONTUSION WAS PATCHED WITH AUTOLOUGUS PERICARDIUM. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1441826 DLP SILICONE RCSP RETROGRADE RETROGRADE RETROGRADE CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF PERFUSION SYSTEMS 94010 UNNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention