BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SI AVANTI PLUS

    MDR report key: 2021538 · Received March 17, 2011

    Report

    Report Number
    9616099-2011-00186
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DRE
    PMA / PMN Number
    K970392
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING AN ELECTROPHYSIOLOGY STUDY THE GUIDE WIRE OF AN AVANTI + SHEATH UNRAVELED / STRETCHED AND SEPARATED. THE PATIENT IS A (B)(6) MALE AND WEIGHS (B)(6). THE REPORT RECEIVED INDICATED THAT ONE OF THE SHORT WIRES FOR AN AVANTI + INTRODUCER (11CM) UNRAVELED WHILE IN THE PATIENT'S LEG DURING AN EP STUDY WITH POSSIBLE ABLATION. IT WAS THE BEGINNING OF THE CASE WHILE OBTAINING ACCESS. THE OUTER WIRE WRAP BROKE AND UNRAVELED. THE CORE AND PART OF THE WRAP (PROXIMAL) WERE REMOVED FROM THE PATIENT, THE DISTAL WRAP "BALLED UP" AND COULD NOT BE REMOVED BUT WAS VISIBLE ON X-RAY. IT WAS EITHER A 6F (LOT# 15291490) OR AN 8F (LOT# 15296499) - BOTH WERE ON THE TABLE, SO IT IS NOT 100% CLEAR WHICH WIRE UNRAVELED. IT WAS SURGICALLY REMOVED FROM THE PATIENT. THE DEVICE APPEARED NORMAL BEFORE THE PROCEDURE. IT WAS HANDLED IN THE USUAL MANNER AND WAS NOT RE-SHAPED. IT WAS A NEW ACCESS IN THE FEMORAL VEIN. THE GUIDEWIRE WAS NOT CAUGHT ON ANY PLAQUE AS NONE WAS PRESENT. THE SCHEDULED PROCEDURE (EP STUDY AND ABLATION) HAD TO BE ABORTED AND WILL NEED TO BE RESCHEDULED AND THEY HAD TO UNDERGO AN UNPLANNED SURGICAL PROCEDURE. THE PRODUCTS ARE NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15291490 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 15291490. THE RECEIVING INSPECTION RECORDS FOR THE WIRE "J" (RC) MINI GUIDE (PART NUMBER: 2702506 AND LOT NUMBER: 201011040035) WERE REVIEWED, AND THIS LOT WAS DEEMED ACCEPTABLE. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCTS AVAILABLE FOR ANALYSIS THE COMPLAINT COULD NOT BE CONFIRMED. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY AND THE DHR REVIEW CONFIRMED THAT THE PRODUCT MET SPECIFICATIONS. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. IT IS DIFFICULT TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT BASED ON THE LIMITED INFORMATION AVAILABLE. THE IFU FOR CAUTIONS: GUIDEWIRES ARE DELICATE INSTRUMENTS AND SHOULD BE HANDLED CAREFULLY. PRIOR TO USE AND WHEN POSSIBLE DURING THE PROCEDURE, INSPECT THE GUIDEWIRE CAREFULLY FOR COIL SEPARATION, BENDS, OR KINKS. DO NOT USE A GUIDEWIRE THAT SHOWS SIGNS OF DAMAGE. DAMAGE WILL PREVENT THE GUIDEWIRE FROM PERFORMING WITH ACCURATE TORQUE RESPONSE AND CONTROL. GUIDEWIRE MANIPULATION/TORQUING SHOULD ALWAYS BE PERFORMED UNDER FLUOROSCOPIC GUIDANCE. NEVER ADVANCE, WITHDRAW OR AUGER THE GUIDEWIRE AGAINST RESISTANCE WITHOUT FIRST DETERMINING THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 9616099-2011-00186 AND 9616099-2011-00187.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THAT ONE OF THE SHORT WIRES FOR AN AVANTI + INTRODUCER (11CM) UNRAVELED WHILE IN THE PATIENT'S LEG DURING AN EP STUDY WITH POSSIBLE ABLATION. IT WAS THE BEGINNING OF THE CASE WHILE OBTAINING ACCESS. THE OUTER WRAP BROKE AND UNRAVELED. THE CORE AND PART OF THE WRAP (PROXIMAL) WERE REMOVED FROM THE PATIENT, THE DISTAL WRAP "BALLED UP" AND COULD NOT BE REMOVED BUT WAS VISIBLE ON X-RAY. IT WAS EITHER A 6F (LOT# 15291490) OR AN 8F (LOT# 15296499) - BOTH WERE ON THE TABLE, SO IT IS NOT 100% CLEAR WHICH WIRE UNRAVELED. IT WAS SURGICALLY REMOVED FROM THE PATIENT. THE DEVICE APPEARED NORMAL BEFORE THE PROCEDURE. IT WAS HANDLED IN THE USUAL MANNER AND WAS NOT RE-SHAPED. IT WAS A NEW ACCESS IN THE FEMORAL VEIN. THE GUIDEWIRE WAS NOT CAUGHT ON ANY PLAQUE AS NONE WAS PRESENT. THE SCHEDULED PROCEDURE (EP STUDY AND ABLATION) HAD TO BE ABORTED AND WILL NEED TO BE RESCHEDULED AND THEY HAD TO UNDERGO AN UNPLANNED SURGICAL PROCEDURE. I DO NOT KNOW IF ANY OTHER ISSUES AROSE WHILE THE PATIENT WAS IN THE OPERATING ROOM AFTER THE PROCEDURE. THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS. THE PATIENT IS A (B)(6) MALE AND WEIGHS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SI AVANTI PLUS CARDIOLOGY VASCULAR ACCESS (DRE) DRE CORDIS DE MEXICO NA 15291490

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| R