BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    MDR report key: 1827783 · Received September 8, 2010

    Report

    Report Number
    3005099803-2010-03886
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 19, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    GCJ
    PMA / PMN Number
    K932553
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT. (B)(4) - REMOVAL OF FOREIGN BODY. (B)(4) - REPORTED ISSUE OF NEEDLE DETACHMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A "POSTERIOR COLPORRHAPHY WITH MESH" PROCEDURE USING A CAPIO DEVICE (TYPE UNKNOWN), THE NEEDLES ATTACHED TO TWO CAPIO SUTURES (MANUFACTURED BY TELEFLEX MEDICAL INC, DISTRIBUTED BY BOSTON SCIENTIFIC CORP) DETACHED INSIDE THE PATIENT. THE FIRST NEEDLE DETACHED IN THE PATIENT'S LEFT LIGAMENT AND THE PHYSICIAN SUCCESSFULLY USED A SECOND SUTURE TO FINISH SUTURING. THE NEEDLE WAS VISUALIZED THROUGH AN X-RAY, BUT WAS DETERMINED BY THE PHYSICIAN TO BE "TOO DEEP TO EXPLORE FURTHER." THE PATIENT HAS REPORTEDLY BEEN INFORMED OF THE UN-RETRIEVED NEEDLE. THE SECOND NEEDLE DETACHED IN THE PATIENT'S RIGHT LIGAMENT AND WAS RETRIEVED BY THE PHYSICIAN THROUGH EXPLORATION OF THE TISSUE AND SITE. THE PROCEDURE WAS COMPLETED WITH THIS CAPIO DEVICE AND THERE REPORTEDLY HAVE BEEN NO POST OP SEQUELAE. FURTHER INFORMATION SURROUNDING THIS EVENT, INCLUDING THE TYPE OF CAPIO DEVICE USED, HAS NOT BEEN FORTHCOMING DESPITE EFFORTS TO FOLLOW UP.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON 09/14/2010 VIA USER FACILITY MEDWATCH # 0300360000-2010-8016 (ATTACHED) THAT DURING A POSTERIOR COLPORRHAPHY WITH MESH AND VAGINAL VAULT SUSPENSION PROCEDURE, A CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE WAS PLACED TO SUTURE THE VAGINAL CUFF. AT THAT TIME, THE NEEDLE AT THE END OF THE CAPIO SUTURE THAT WAS BEING THROWN WITH THE CAPIO DEVICE DETACHED AND WAS LOST INSIDE THE PATIENT. THE PHYSICIAN WAS UNABLE TO PALPATE THE NEEDLE OR FIND IT IN THE SPONGES. AN X-RAY WAS PERFORMED AND THE NEEDLE WAS SEEN ON THE LEFT PUBIC RAMUS. THE NEEDLE WAS NOTED TO BE IN AN AREA THAT COULD NOT BE PALPATED OR SEEN, AND DISSECTION TO THE AREA WAS DETERMINED TO BE OF GREATER RISK TO THE PATIENT THAN LEAVING THE NEEDLE INSIDE THE PATIENT. THE NEEDLE WAS HENCE LEFT IN PLACE AND THE PATIENT AND THE PATIENT'S FAMILY WERE NOTIFIED OF THIS INCIDENT AND SHOWN THE X-RAYS. A SECOND CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE WAS THEN USED WITH A SECOND CAPIO SUTURE AND THE NEEDLE ATTACHED TO THAT SUTURE DETACHED INSIDE THE PATIENT AS WELL, BUT WAS RETRIEVED. PER FOLLOW-UP INFORMATION RECEIVED ON (B)(6) 2010, THE PATIENT WEIGHED (B)(6) AT THE TIME OF THE INCIDENT AND IS DOING "FINE" POST-PROCEDURE. THE PHYSICIAN'S OPINION, PER THE ATTACHED USER FACILITY MEDWATCH, IS THAT THIS INCIDENT "WAS AN EQUIPMENT ERROR." WHILE THIS REPORT, THAT IS A SUPPLEMENT TO MANUFACTURER REPORT # 3005099803-2010-03886, PERTAINS TO THE FIRST CAPIO DEVICE, INITIAL MANUFACTURER REPORT # 300509983-2010-04295 PERTAINS TO THE SECOND CAPIO DEVICE, WHOSE INVOLVEMENT WAS REPORTED TO BSC ON (B)(6) 2010 VIA THE ATTACHED USER FACILITY MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE SUTURE PLACEMENT SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ BOSTON SCIENTIFIC - MIAMI M0068311250 13388486

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other| R MESH (MANUFACTURER UNKNOWN)| CAPIO SUTURES (MANUFACTURER: TELEFLEX MEDICAL INC)