BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS? SR PRO

    MDR report key: 3240889 · Received July 22, 2013

    Report

    Report Number
    2134265-2013-04932
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    RESPONSE TO FDA REQUEST: REQUEST 1. PLEASE CONFIRM OR PROVIDE THE MODEL, LOT, SERIAL, AND/OR CATALOG NUMBER(S) OF THE DEVICE LISTED IN THE MEDICAL DEVICE REPORT AS APPLICABLE. RESPONSE: THE IDENTIFYING NUMBERS FOR THE COMPLAINT DEVICE ARE: MODEL/UPN: H749389420. CATALOG NUMBER: 38942. BATCH/LOT NUMBER: 13805975. REQUEST 2. PLEASE PROVIDE THE DEVICE IMPLANT AND EXPLANT DATE, AND/OR THE DURATION OF IMPLANT TIME. IF THE IMPLANT WAS EXPLANTED, PLEASE PROVIDE THE REASON. RESPONSE: THERE ARE NO IMPLANT OR EXPLANT DATES AS THE ATLANTIS SR PRO IS AN IMAGING CATHETER, NOT AN IMPLANTABLE DEVICE. REQUEST 3. PLEASE VERIFY THE DATES INCLUDED IN THIS REPORT. THE LISTING FOR THE DEVICE MANUFACTURED AND EXPIRATION DATES ARE 2010 AND 2011 RESPECTIVELY, YET THE REPORT DATE IS 2013. IF THIS IS CORRECT, THEN WHY WAS THIS DEVICE USED AFTER THE EXPIRATION DATE? RESPONSE: THE REPORTED EVENT DATE IS CORRECT. NO INFORMATION WAS OBTAINED ABOUT THE FACILITIES PRE-OPERATING PROCEDURES. HOWEVER IT WAS REPORTED THAT A SENIOR NURSE RECOGNIZED THAT THE DEVICE WAS EXPIRED AND SEPARATED IT FROM THE OTHER ATLANTIS SR PROS WITHOUT TELLING THE OTHER MEMBERS WHO ARE IN THE CATH ROOM AND THAT IT WAS MISTAKENLY PICKED AND USED IN THE PROCEDURE. DEVICE EVALUATION: A DEVICE WITH A LABEL FOR LOT# 13805975 WAS RECEIVED FOR INVESTIGATION. THE FOLLOWING WAS OBSERVED; THE DISTAL TIP ASSEMBLY WAS BROKEN OFF AND MISSING APPROXIMATELY 6.0CM LONG WHEN RECEIVED. THE TIP WAS BRITTLE AND ADDITIONAL PIECES BROKE OFF DURING HANDLING OF THE CATHETER DURING PRODUCT ANALYSIS. DURING IMAGE CHARACTERIZATION TESTING IN THE ROLLER COASTER MODEL, A GOOD SQUARE IMAGE APPEARED IN THE SYSTEM AND THE PRODUCT PERFORMED WITHIN SPECIFICATION. NO OTHER ISSUES OR DEFECTS WERE OBSERVED DURING PRODUCT ANALYSIS OF THE RETURNED DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE OF THE REPORTED COMPLAINT HAS BEEN DETERMINED TO BE USER RELATED AS PER THE DFU THE FOLLOWING INSTRUCTIONS WERE NOT FOLLOWED: DO NOT USE DEVICE AFTER INDICATED ¿USE BY¿ DATE. USE OF AN EXPIRED DEVICE COULD RESULT IN PATIENT INJURY DUE TO DEVICE DEGRADATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, TIP SEPARATION OCCUR. THE 70% STENOSED TARGET LESION WAS LOCATED IN SEVERE TORTUOUS AND MODERATE CALCIFIED PROXIMAL TO MID RIGHT CORONARY ARTERY. DURING REMOVAL OF ATLANTIS SR PRO CATHETER, TIP OF THE CATHETER GOT SEPARATED AND REMAINED INSIDE THE PATIENT (REMAINED PART WAS ABOUT 2 OR 3CM). SNARE WAS USED TO REMOVE REMAINED PART BUT FAILED. THEN, MARVERICK WAS USED TO TRY TO REMOVE REMAINED PART USING DOUBLE BALLOON, BUT FAILED. EVENTUALLY, THE REMAINED PART WAS ATTACHED TO VESSEL WALL WITH STENT (PE PLUS WAS USED) AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, TIP SEPARATION OCCUR. THE 70% STENOSED TARGET LESION WAS LOCATED IN SEVERE TORTUOUS AND MODERATE CALCIFIED PROXIMAL TO MID RIGHT CORONARY ARTERY. DURING REMOVAL OF ATLANTIS SR PRO CATHETER, TIP OF THE CATHETER GOT SEPARATED AND REMAINED INSIDE THE PATIENT (REMAINED PART WAS ABOUT 2 OR 3CM). SNARE WAS USED TO REMOVE REMAINED PART BUT FAILED. THEN, MARVERICK WAS USED TO TRY TO REMOVE REMAINED PART USING DOUBLE BALLOON, BUT FAILED. EVENTUALLY, THE REMAINED PART WAS ATTACHED TO VESSEL WALL WITH STENT (PE PLUS WAS USED) AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341407 ATLANTIS? SR PRO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT (SUD) H749389420 13805975

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention