BEUDAMED
    FDA Adverse Event Death Summary report: N

    KIWI COMPLETE VACUUM DELIVERY SYSTEM

    MDR report key: 7106715 · Received December 11, 2017

    Report

    Report Number
    1722684-2017-00015
    Event Type
    Death
    Date Received
    December 11, 2017
    Date of Event
    October 1, 2017
    Report Date
    January 19, 2018
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    HDB
    PMA / PMN Number
    K981260
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBGALEAL HEMORRHAGES ARE VERY RARE COMPLICATIONS (REPORTED AS LOW AS 4 PER 10,000 TO 8 PER 1000 DELIVERIES) ASSOCIATED WITH VACUUM-ASSISTED VAGINAL DELIVERIES. RISK FACTORS FOR THIS TYPE OF HEMORRHAGE INCLUDE: NULLIPARITY, MALPOSITION, MISPLACEMENT OF THE CUP, PROLONGED TRACTION EFFORTS, AND POP-OFFS/DETACHMENTS OF THE VACUUM CUP. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. WE ARE STILL IN THE PROCESS OF ASSESSING THE INCIDENT AND THE PATIENT'S CURRENT CONDITION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INVESTIGATION FROM THE HOSPITAL REVEALED THE PATIENT WAS AT 41.1 WEEKS GESTATION AND THIS WAS HER 4TH PREGNANCY-ALL PREVIOUS DELIVERIES WERE VAGINAL. THE REPORTED INDICATION FOR THE PROCEDURE WAS SEVERE VARIABLE DECELERATIONS (CATEGORY III TRACING) DURING THE SECOND STAGE OF LABOR. IT WAS REPORTED THAT THE INFANT WAS IN THE OCCIPUT POSTERIOR (OP) POSITION AND AT +2 STATION. THE VACUUM WAS APPLIED TWICE (1 POP-OFF OR CUP DETACHMENT) AND THREE PULLS WERE CONDUCTED. NO PROGRESS WAS SEEN WITH THE 2ND AND 3RD PULLS, THUS THE DELIVERY WAS CONVERTED TO AN EMERGENT CESAREAN SECTION. INITIAL APGAR SCORES WERE 8 AND 9, HOWEVER, SIGNIFICANT CRANIAL SWELLING WAS NOTED. FURTHER EVALUATION REVEALED SKULL FRACTURES AND EVIDENCE OF A SUBGALEAL HEMORRHAGE. THE INFANT WAS TRANSFERRED TO A TERTIARY CARE CENTER AND REPORTEDLY DECEASED WITHIN A WEEK. THE VACUUM PRODUCT WAS NOT RETAINED, NOR WAS THE LOT NUMBER PROVIDED. SUBGALEAL HEMORRHAGES AND SKULL FRACTURES ARE VERY RARE COMPLICATIONS (REPORTED AS LOW AS 4 PER 10,000 TO 8 PER 1,000 DELIVERIES) ASSOCIATED WITH VACUUM-ASSISTED DELIVERIES AND ARE NOTED IN THE PRODUCT PACKAGING. RISK FACTORS FOR THESE TYPE OF INJURIES INCLUDE: NULLIPARITY, MALPOSITION, MISPLACEMENT OF THE CUP ON THE FETAL HEAD, PROLONGED TRACTION EFFORTS, POP-OFFS/DETACHMENTS OF THE VACUUM CUP AND FETAL DISTRESS (CATEGORY III TRACINGS). FOLLOW-UP EDUCATION INCLUDING REVIEW OF INDICATIONS, CONTRAINDICATIONS, AND TECHNIQUES, AS WELL AS HANDS-ON SIMULATION WITH THE DEVICE WILL BE PROVIDED THIS HOSPITAL FACILITY IN FEBRUARY 2018 AS FOLLOW-UP TO THIS UNFORTUNATE INCIDENT, AT THE REQUEST OF THE DEPARTMENTAL CHAIR.

    Description of Event or Problem · 1

    (SUBGALEAL OUTCOME). THE OB USED KIWI FOR THE DURATION OF 3 CONTRACTIONS AND HAD ONE POP-OFF.

    Description of Event or Problem · 1

    (SUBGALEAL OUTCOME). THE OB USED KIWI FOR THE DURATION OF 3 CONTRACTIONS AND HAD ONE POP-OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883289 KIWI COMPLETE VACUUM DELIVERY SYSTEM FOETAL VACUUM DELIVERY SYSTEM HDB CLINICAL INNOVATIONS, LLC UKNOWN UKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L