BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIA ACCESSET EMBRYO TRANSFER CATHETER

    MDR report key: 4322187 · Received December 1, 2014

    Report

    Report Number
    1820334-2014-00612
    Event Type
    Malfunction
    Date Received
    December 1, 2014
    Date of Event
    October 29, 2014
    Report Date
    October 29, 2014
    Manufacturer
    COOK, INC.
    Product Code
    MQF
    UDI-DI
    00827002530072
    PMA / PMN Number
    K983594
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DURING INVESTIGATION, A REVIEW OF THE DEVICE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU) PAMPHLET, MANUFACTURING INSTRUCTIONS (MI), QUALITY CONTROL (QC) PROCEDURES, DEVICE SPECIFICATIONS AND A VISUAL INSPECTION OF THE RETURNED PHOTOGRAPH OF THE USED DEVICE. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED, SO NO PHYSICAL EVALUATION COULD BE PERFORMED ON THE ACTUAL DEVICE. THE RETURNED PHOTO OF THE USED DEVICE SHOWED THE METAL CANNULA WITHIN THE TRANSFER CATHETER HAD PERFORATED THE DISTAL GUIDE CATHETER. THIS MOST LIKELY OCCURRED AS A RESULT OF EXCESSIVE FORCE AS THE PHYSICIAN ATTEMPTED TO ADVANCE THE INNER CATHETER, BUT WAS FACED WITH RESISTANCE AS THE GEOMETRY OF THE PLACED GUIDE CATHETER MAY NOT HAVE ALLOWED FOR A SMOOTH TRANSITION. MANUFACTURING INSTRUCTIONS (MI) SPECIFY THAT THE "TRANSFER CATHETER MOVES FREELY THROUGH THE GUIDE CATHETER" AND THAT THE "END HOLE OF THE TRANSFER CATHETER MUST BE ROUND AND SMOOTH". THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATION. A RISK ASSESSMENT OF THE EVENT WAS CONDUCTED AND CONCLUDED THAT NO FURTHER RISK REDUCTION ACTIVITIES WERE REQUIRED AT THIS TIME. THE ROOT CAUSE OF THE INCIDENT WAS DETERMINED TO HAVE BEEN USER ERROR. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 19, 201 5 STATED THAT THE PATIENT DID NOT GET PREGNANT WITH THE LOST EMBRYO PATIENT WILL REPEAT FROZEN EMBRYO TRANSFER AT NATURAL CYCLE.

    Description of Event or Problem · 1

    DURING THE ET PROCEDURE, THE DOCTOR PUT THE OUTER CATHETER IN THE PATIENT. ALTHOUGH HE MET A LITTLE RESISTANCE HE WAS ABLE TO PLACE IT. WHEN INTRODUCING THE INNER CATHETER IT STARTED OK, THEN THE DOCTOR MET RESISTANCE AGAIN. HE SENSED SOMETHING WAS WRONG AND PULLED THE CATHETER OUT. AT THIS TIME, THEY SAW THE CATHETERS AND THEY BELIEVED THE OUTER CATH DID NOT HOLD THE INNER CATH AND THE INNER CATHETER SEEMS TO HAVE GONE THROUGH CX OR UTERUS THEY LOOKED FOR THE EMBRYO BUT IT WAS NOT TO BE FOUND. ADDITIONAL INFORMATION FROM THE REP PROVIDED (B)(6) 2014: IT'S HARD TO SAY IF IT WAS A PATIENT INJURY. THE EMBRYO WAS LOT. THE REP THINKS THE DEVICE WAS NOT HANDLED CORRECTLY BY THE PHYSICIAN. IF THE DOCTOR FEELS RESISTANCE - HE SHOULD NOT PRESS FURTHER. ADDITIONAL INFORMATION RECEIVED FROM THE REP ON (B)(6) 2014: "IT WAS THE CERVIX THAT WAS PERFORATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775496 GUARDIA ACCESSET EMBRYO TRANSFER CATHETER CATHETER, ASSISTED REPRODUCTION MQF COOK, INC. NA 5149585 00827002530072

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other