BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1925624 · Received December 14, 2010

    Report

    Report Number
    2953144-2010-03232
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES, CONTINUED: 0.035 GUIDEWIRE, HEPARIN, DILATATION CATHETER: CORDIS MAXI. SHEATH: 14FR CORDIS. THE DEVICE WAS DISCARDED AT THE FACILITY, THE LOT NUMBER WAS IDENTIFIED. REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. THE PROSTAR INSTRUCTIONS FOR USE INDICATE: REMOVE THE PROSTAR XL SHEATH BEFORE TIGHTENING THE SUTURE. FAILURE TO REMOVE THE SHEATH PRIOR TO TIGHTENING THE SUTURE MAY RESULT IN DETACHMENT OF THE TIP OF THE SHEATH. IF USING THE PRE-CLOSE TECHNIQUE (PLACEMENT OF THE PROSTAR XL DEVICE SUTURES PRIOR TO DILATING THE ACCESS SITE BEYOND 10F), SUTURES SHOULD BE GRADUALLY TIGHTENED AS THE INTRODUCER SHEATH IS REMOVED TO MAINTAIN HEMOSTASIS. ALSO, IF USING THE PRE-CLOSE TECHNIQUE, SUTURES SHOULD BE GRADUALLY TIGHTENED AS THE INTRODUCER SHEATH IS REMOVED TO MAINTAIN HEMOSTASIS. DO NOT TIGHTEN THE SUTURE AROUND THE PROSTAR XL SHEATH. BASED ON THE EVENT INFORMATION, THE ROOT CAUSE HAS BEEN DETERMINED TO BE MOST LIKELY RELATED TO USER ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PHYSICIANS, IN-TRAINING IN THE USE OF THE PROSTAR DEVICE, ATTEMPTED A PRE-CLOSURE TECHNIQUE OF THE 5.5 MM RIGHT COMMON FEMORAL ARTERY (RCFA) PRIOR TO AN AORTIC STENTING AND VALVULOPLASTY PROCEDURE. REPORTEDLY, THE PROSTAR 10 FR DEVICE WAS BEING USED AS CLOSURE OF A 14 FR FEMORAL PUNCTURE. THE DEVICE WAS DEPLOYED IN THE RCFA WITHOUT ISSUES, THE SUTURES WERE HARVESTED. UPON COMPLETION OF THE INTERVENTIONAL CASE, A 0.035 GUIDE WIRE WAS RE-INSERTED INTO THE 14FR SHEATH IN SITU. THE PHYSICIANS PRE-TIED THE SUTURES AND ADVANCED THE SUTURE KNOT TOWARDS THE SHEATH IN THE RCFA FOR CLOSURE, PRIOR TO THE SHEATH BEING COMPLETELY REMOVED FROM THE VESSEL. THE SUTURE WAS TIGHTENED AND LOCKED ON THE SHEATH AS THE SHEATH WAS BEING REMOVED. THE PHYSICIANS WERE UNABLE TO REMOVE THE SHEATH OR CUT THE SUTURE TO RELEASE THE SHEATH. HEMOSTASIS WAS NOT ABLE TO BE ACHIEVED; THEY WERE UNABLE TO VISUALIZE THE SUTURE ON THE SHEATH TO CUT THE SUTURE. A VASCULAR SURGEON WAS CALLED IN TO CONTROL THE BLEEDING. THE 14FR SHEATH WAS REMOVED AND THE VESSEL INSPECTED; THERE WAS NO DAMAGE TO THE VESSEL WALL, NO PERFORATIONS WERE SEEN. THE VESSEL WAS SURGICALLY CLOSED. PROTAMINE WAS ADMINISTERED TO REVERSE THE HEPARIN. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-REDWOOD CITY 860346H

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention