BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICROSS 40 MHZ CORONARY IMAGING CATHETER

    MDR report key: 1931798 · Received December 17, 2010

    Report

    Report Number
    2939204-2010-01139
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT AVAILABLE FOR EVALUATION; THEREFORE PRODUCT INSPECTION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THE LOT AND NO ISSUES OR DISCREPANCIES WERE FOUND. NO SIMILAR COMPLAINTS WERE FOUND IN THIS LOT. THE DEVICE LABELING AND DIRECTIONS FOR USE (B)(4) WERE REVIEWED AND REVEALED THAT THE LABELING AND/OR DFU CONTAINS THESE WARNINGS: "NEVER ADVANCE OR WITHDRAW THE IMAGING CATHETER WITHOUT FLUOROSCOPIC VISUALIZATION BECAUSE IT MAY CAUSE VESSEL INJURY OR PATIENT COMPLICATIONS. DO NOT ADVANCE THE CATHETER IF RESISTANCE IS ENCOUNTERED. THE CATHETER SHOULD NEVER BE FORCIBLY INSERTED INTO LUMENS NARROWER THAN THE CATHETER BODY OR FORCED THROUGH A TIGHT STENOSIS. A CATHETER THAT IS FORCIBLY ADVANCED MAY CAUSE CATHETER DAMAGE RESULTING IN VESSEL INJURY OR PATIENT COMPLICATIONS. IF RESISTANCE IS MET UPON WITHDRAWAL OF THE CATHETER, VERIFY RESISTANCE USING FLUOROSCOPY, THEN REMOVE THE ENTIRE SYSTEM SIMULTANEOUSLY. A CATHETER THAT IS FORCIBLY REMOVED MAY CAUSE VESSEL INJURY OR PATIENT COMPLICATIONS. WHEN ADVANCING THE CATHETER THROUGH A STENTED VESSEL, CATHETERS THAT DO NOT COMPLETELY ENCAPSULATE THE GUIDEWIRE MAY ENGAGE THE STENT BETWEEN THE JUNCTION OF THE CATHETER AND GUIDEWIRE, RESULTING IN ENTRAPMENT OF CATHETER/GUIDEWIRE, CATHETER TIP SEPARATION, AND/OR STENT DISLOCATION. WHEN READVANCING A GUIDEWIRE AFTER DEPLOYMENT OF STENT(S), AT NO TIME SHOULD A CATHETER BE ADVANCED ACROSS A GUIDEWIRE THAT MAY BE PASSING BETWEEN ONE OR MORE STENT STRUTS. A GUIDEWIRE MAY EXIT BETWEEN ONE OR MORE STENT STRUTS WHEN RECROSSING STENT(S). SUBSEQUENT ADVANCEMENT OF THE CATHETER COULD CAUSE ENTANGLEMENT BETWEEN THE CATHETER AND THE STENT(S), RESULTING IN ENTRAPMENT OF CATHETER/GUIDEWIRE, CATHETER TIP SEPARATION AND/OR STENT DISLOCATION. USE CAUTION WHEN REMOVING THE CATHETER FROM A STENTED VESSEL. INADEQUATELY APPOSED STENTS, OVERLAPPING STENTS, AND/OR SMALL STENTED VESSELS WITH DISTAL ANGULATION MAY LEAD TO ENTRAPMENT OF THE CATHETER WITH THE STENT UPON RETRACTION. WHEN RETRACTING THE CATHETER, ENSURE THAT THE SHORT RAIL DISTAL TIP IS PARALLEL TO THE GUIDEWIRE. SEPARATION OR BENDING OF THE GUIDEWIRE MAY RESULT IN KINKING OF THE GUIDEWIRE, DAMAGE TO THE CATHETER DISTAL TIP, AND/OR VESSEL INJURY. THE LOOPED GUIDEWIRE OR DAMAGED TIP MAY CATCH ON THE STENT STRUT RESULTING IN ENTRAPMENT. THE REVIEW OF THE DEVICE LABELING FOUND THAT THE CATHETER WAS POSSIBLY USED AGAINST THE LABELING AND/OR DIRECTIONS FOR USE AS IT WARNS AGAINST PULLING WHEN RESISTANCE IS MET. IT WAS REPORTED THAT UPON GETTING STUCK THE PHYSICIAN PULLED THE CATHETER AGAINST RESISTANCE; THE CATHETER TIP SEPARATED. ALTHOUGH THE PRODUCT WAS NOT RETURNED, BASED ON THE EVENT DESCRIPTION AND THE RESULTS OF THE DHR AND SIMILAR COMPLAINT REVIEWS, IT APPEARS THAT THE DEVICE MET ALL REQUIRED SPECIFICATIONS. A PROBABLE ROOT CAUSE OF OPERATIONAL CONTEXT WAS ASSIGNED TO THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) THE PHYSICIAN SUCCESSFULLY USED THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER TO VISUALIZE THE SAPHENOUS VEIN GRAFT (SVG ) IN PREPARATION FOR ADDITIONAL DEVICE PLACEMENT. THE PHYSICIAN FELT RESISTANCE UPON REMOVAL OF THE IVUS CATHETER, THROUGH A PREVIOUSLY PLACED STENT(S), THE CATHETER BECAME STUCK UPON REMOVAL OF THE IVUS CATHETER FROM THE PATIENT IT WAS NOTED 2-3 CM OF THE DISTAL TIP HAD DETACHED FROM THE CATHETER AND REMAINED INSIDE THE PATIENT. THE PHYSICIAN USED A GUIDEWIRE, BALLOON AND SNARE IN ATTEMPTS TO RETRIEVE THE TIP THAT REMAINED INSIDE THE PATIENT, HOWEVER, HE WAS UNSUCCESSFUL. THE PATIENT WAS SENT TO SURGERY WHERE IT IS BELIEVED THAT THE TIP WAS SUCCESSFULLY REMOVED AND THE PATIENT IS IN GOOD CONDITION.

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) THE PHYSICIAN SUCCESSFULLY USED THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER TO VISUALIZE THE SAPHENOUS VEIN GRAFT (SVG ) IN PREPARATION FOR ADDITIONAL DEVICE PLACEMENT. THE PHYSICIAN FELT RESISTANCE UPON REMOVAL OF THE IVUS CATHETER, THROUGH A PREVIOUSLY PLACED STENT(S), THE CATHETER BECAME STUCK UPON REMOVAL OF THE IVUS CATHETER FROM THE PATIENT IT WAS NOTED 2-3 CM OF THE DISTAL TIP HAD DETACHED FROM THE CATHETER AND REMAINED INSIDE THE PATIENT. THE PHYSICIAN USED A GUIDEWIRE, BALLOON AND SNARE IN ATTEMPTS TO RETRIEVE THE TIP THAT REMAINED INSIDE THE PATIENT, HOWEVER HE WAS UNSUCCESSFUL. THE PATIENT WAS SENT TO SURGERY WHERE IT IS BELIEVED THAT THE TIP WAS SUCCESSFULLY REMOVED AND THE PATIENT IS IN GOOD CONDITION.

    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 13834945

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R MEDTRONIC - EBU 6F, 3.75 GC| GUIDANT - BMW .014 GW