BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOSYN

    MDR report key: 15020540 · Received July 14, 2022

    Report

    Report Number
    9612501-2022-01178
    Event Type
    Injury
    Date Received
    July 14, 2022
    Date of Event
    March 23, 2021
    Report Date
    July 26, 2024
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: STERNOTOMY WITH ELECTROCAUTERY AND STERNAL WOUND INFECTION IN CONGENITAL HEART SURGERY IN PATIENTS UNDER 1 YEAR OF AGE SOURCE: DOI: 10.1111/JOCS.15561, 2021 WILEY PERIODICALS LLC WILEYONLINELIBRARY.COM/JOURNAL/JOCS J CARD SURG. 2021;36:2336¿2341. 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 · 0

    D10: UNKNOWN POLYSORB SUTURE (LOT#UNK); UNKNOWN BIOSYN (LOT#UNK) H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS NOT RETURNED, BUT A PHOTO WAS AVAILABLE FOR EVALUATION. THE EVALUATION FOUND NO POTENTIALLY CONTRIBUTING FACTORS. IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED A MEDICAL COMPLICATION AS A RESULT OF DEVICE USAGE. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE IDENTIFIED BECAUSE NO RELATED PROBLEM WAS DETECTED WITH THE DEVICE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. 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 · 0

    ADDITIONAL INFORMATION: G3, H3 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS NOT RETURNED, BUT A PHOTO WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PHOTO(S) NOTED SEVERAL TIED OFF SUTURES AT THE SURGICAL SITE. THE COLOR OF THE SUTURES WERE DARK IN COLOR. DUE TO IMAGE QUALITY THE CONDITION OF THE SUTURES COULD NOT BE DETERMINED. IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED A MEDICAL COMPLICATION AS A RESULT OF DEVICE USAGE. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED, A TOTAL OF 435 STERNOTOMY WERE PERFORMED IN 423 PATIENTS UNDER 1 YEAR OF AGE. THE RETROSPECTIVE STUDY AIMED TO COMPARE THE RATE OF WOUND SITE INFECTION IN PATIENTS <(><<)>1 YEAR OF AGE WHO UNDERWENT STERNOTOMY USING ELECTROCAUTERY. THIS DOUBLE-CENTER STUDY INCLUDED PATIENTS UNDER 1 YEAR OF AGE WHO UNDERWENT CARDIAC SURGERY VIA STERNOTOMY PERFORMED WITH ELECTROCAUTERY FOR CONGENITAL HEART DISEASE BETWEEN JANUARY 2017 AND JUNE 2019. SUTURE WAS USED IN ALL PATIENTS TO CLOSE THE SKIN. COMPLICATION INCLUDES: SIX (6) PATIENTS HAD SUPRASTERNAL WOUND INFECTION AND REDNESS. ALL 6 PATIENTS WITH WOUND INFECTION ALSO EXPERIENCED SUPERFICIAL SKIN DEHISCENCE. A SAMPLE FOR CULTURE WAS OBTAINED FROM THE WOUND SITE AND THE WOUND DRESSING WAS PERFORMED DAILY USING POVIDONE-IODINE. A BROAD-SPECTRUM ANTIBIOTIC WAS COMMENCED FOR PROPHYLAXIS UNTIL THE RESULT OF WOUND CULTURE WAS OBTAINED. THE PATIENTS WHO WERE POSITIVE FOR CULTURE RECEIVED ANTIBIOTIC TREATMENT IN ACCORDANCE WITH THE RESULTS OF ANTIBIOGRAM. WOUND SITE WAS PRIMARILY CLOSED UNDER STERILE CONDITIONS IN THE PATIENTS WHO WERE NEGATIVE FOR CULTURE. ONE (1) PATIENT HAD MEDIASTINITIS. OPEN WOUND CARE WAS PERFORMED IN THIS PATIENT; GROWTH WAS DETECTED IN THE WOUND CULTURE AND ACCORDINGLY APPROPRIATE ANTIBIOTIC TREATMENT WAS STARTED. WOUND DEBRIDEMENT AND NEGATIVE PRESSURE WOUND THERAPY WERE PERFORMED. DETECTING NO GROWTH IN THE WOUND CULTURES OBTAINED SEQUENTIALLY, THE STERNUM WAS CLOSED UNDER STERILE CONDITIONS AND THE PATIENT WAS DISCHARGED ON THE POSTOPERATIVE 53RD DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2062985 UNKNOWN BIOSYN SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM DAVIS & GECK CARIBE LTD UNKNOWN BIOSYN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention UNKNOWN POLYSORB SUTURE (LOT#UNK)