BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICROSS 40 MHZ CORONARY IMAGING CATHETER

    MDR report key: 1564167 · Received December 16, 2009

    Report

    Report Number
    2939204-2009-00921
    Event Type
    Injury
    Date Received
    December 16, 2009
    Date of Event
    September 4, 2009
    Report Date
    November 17, 2009
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SHIP HISTORY WAS PERFORMED TO IDENTIFY THE DEVICE LIKELY UTILIZED IN THIS PROCEDURE. REVIEW OF THE SHIP HISTORY IDENTIFIED 3 POTENTIAL LOTS. THE DEVICE HISTORY RECORD (DHR) AND SIMILAR COMPLAINTS WERE REVIEWED FOR THESE LOTS AND NO ISSUES WERE IDENTIFIED RELATED TO THE REPORTED EVENT. A REVIEW OF THE DEVICE LABELING AND DIRECTIONS FOR USE (DFU) CONTAINS THE FOLLOWING COMPLICATIONS: THE RISKS AND DISCOMFORTS INVOLVED IN VASCULAR IMAGING INCLUDE THOSE ASSOCIATED WITH ALL CATHETERIZATION PROCEDURES. THESE RISKS OR DISCOMFORTS MAY OCCUR AT ANY TIME WITH VARYING FREQUENCY OR SEVERITY. ADDITIONALLY, THESE COMPLICATIONS MAY NECESSITATE ADDITIONAL MEDICAL TREATMENT INCLUDING SURGICAL INTERVENTION AND, IN RARE INSTANCES, RESULT IN DEATH. VESSEL OCCLUSION AND ABRUPT CLOSURE. THE REVIEW OF THE DEVICE LABELING FOUND NO EVIDENCE OR INDICATION THAT THE CATHETER WAS USED AGAINST THE LABELING AND/OR DIRECTIONS FOR USE. THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION AS IT WAS DISPOSED BY THE FACILITY; THEREFORE PRODUCT INSPECTION COULD NOT BE PERFORMED. THERE IS NO INDICATION THAT THE DEVICE MALFUNCTIONED. THE REPORTED PATIENT COMPLICATION IS NOTED IN THE DFU AS AN ANTICIPATED PROCEDURAL COMPLICATION TO THESE TYPES OF PROCEDURES AND AS SUCH, HAS BEEN ASSIGNED AS THE ROOT CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE SUSPECT DEVICE IS UNK; THEREFORE, THE MFR AND EXP DATES CANNOT BE DETERMINED. THE DEVICE WAS DISPOSED BY THE FACILITY; THEREFORE, A DEVICE EVAL CANNOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ENROLLED IN THE CLINICAL TRIAL FOR TREATMENT OF DE NOVO CORONARY ARTERY LESIONS UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A SIGNIFICANT 85% STENOSIS OF THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS BALLOON PRE-DILATED, FOLLOWED BY THE ADVANCEMENT OF AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER INTO THE LAD. AFTER IVUS CATHETER INSERTION, THE PATIENT COMPLAINED OF CHEST PAIN; HOWEVER, IT SUBSIDED RAPIDLY. A DRUG ELUDING STENT (DES) WAS DEPLOYED ACROSS THE TARGET LESION. AN IVUS POST RUN WAS PERFORMED FOLLOWED BY SERIAL BALLOON INFLATIONS (3) WITH A DIFFERENT BALLOON. A THIRD IVUS RUN WAS PERFORMED TO INTERROGATE THE MID LAD LESION, FOLLOWED BY A BALLOON PRE-DILATION AND A FOURTH IVUS RUN. ANOTHER DES WAS PLACED IN THE MID LAD LESION (75% STENOSIS), DOVETAILING THE PROXIMAL STENT AND THUS STABILIZING THE VESSEL. FAVORABLE ANGIOGRAPHIC AND IVUS IMAGES WERE OBTAINED POST STENT DEPLOYMENT. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. PROCEDURE NOTES INDICATE IVUS REVEALED A SIGNIFICANT PLAQUE DISRUPTION JUST DISTAL TO THE FIRST STENTED SEGMENT, THEREFORE DECIDED TO PLACE A SECOND STENT. IVUS WAS NOT THE REASON FOR THE OCCLUSIVE COMPLICATION, ACCORDING TO THE TREATING SITE. SAME AS MFR REPORT #2134265-2009-07232.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT ENROLLED IN THE CLINICAL TRIAL FOR TREATMENT OF DE NOVO CORONARY ARTERY LESIONS UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A SIGNIFICANT 85% STENOSIS OF THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS BALLOON PRE-DILATED, FOLLOWED BY THE ADVANCEMENT OF AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER INTO THE LAD. AFTER IVUS CATHETER INSERTION, THE PT COMPLAINED OF CHEST PAIN; HOWEVER, IT SUBSIDED RAPIDLY. A DRUG ELUDING STENT (DES) WAS DEPLOYED ACROSS THE TARGET LESION. AN IVUS POST RUN WAS PERFORMED FOLLOWED BY SERIAL BALLOON INFLATIONS (3) WITH A DIFFERENT BALLOON. A THIRD IVUS RUN WAS PERFORMED TO INTERROGATE THE MID LAD LESION, FOLLOWED BY A BALLOON PRE-DILATION AND A FOURTH IVUS RUN. ANOTHER DES WAS PLACED IN THE MID LAD LESION (75% STENOSIS), DOVETAILING THE PROXIMAL STENT AND THUS, STABILIZING THE VESSEL. FAVORABLE ANGIOGRAPHIC AND IVUS IMAGES WERE OBTAINED POST STENT DEPLOYMENT. THE PT WAS DISCHARGED THE FOLLOWING DAY. PROCEDURE NOTES INDICATES IVUS REVEALED A SIGNIFICANT PLAQUE DISRUPTION JUST DISTAL TO THE FIRST STENTED SEGMENT, THEREFORE DECIDED TO PLACE A SECOND STENT. IVUS WAS NOT THE REASON FOR THE OCCLUSIVE COMPLICATION, ACCORDING TO THE TREATING SITE. SAME AS MFR REPORT # 2134265-2009-07232.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICROSS 40 MHZ CORONARY IMAGING CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT H749518050 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R ACCESS WIRE: J3MM EMERALD| BALLOON: APEX MONORAIL (BSC)| SHEATH INTRODUCER: 6 FR PINNACLE INTRODUCER| GUIDEWIRE: COUGAR XT| GUIDE CATHETER: EBU 3.5 SHERPA