BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTICROSS?

    MDR report key: 4173741 · Received October 15, 2014

    Report

    Report Number
    2134265-2014-06357
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    OBJ
    PMA / PMN Number
    K123621
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RECEIVED FOR EVALUATION. EVALUATION OF THE RETURNED DEVICE REVEALED THE DEVICE WAS RETURNED WITH THE SHEATH DETACHED FROM THE TELESCOPE ASSEMBLY AT THE TELESCOPE DISTAL STRAIN RELIEF. THE REST OF THE DEVICE WAS RETURNED WITH THE INTRODUCER USED FOR THIS PROCEDURE. VARIOUS KINKS WERE FOUND ON THE DEVICE. THE SHEATH WAS FOUND WITHIN THE INTRODUCER. THE IMAGING WINDOW WAS FOUND DETACHED FROM THE DEVICE. THE IMAGING WINDOW WAS FOUND DETACHED FROM THE DEVICE. A GUIDE WIRE WAS STUCK IN THE DISTAL TIP IN THE GUIDEWIRE HOLE. A STENT WAS TRAPPED AROUND THE DISTAL TIP AND GUIDEWIRE. 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 IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STUCK IN STENT AND VESSEL PERFORATION OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT MAIN CORONARY ARTERY (LMCA) TO PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A NON-BSC GUIDE WIRE WAS ADVANCED TO THE LESION. PRE-DILATATION WAS PERFORMED WITH A 3.0 X 15MM NON-BSC SEMI-COMPLIANT BALLOON. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED USING AN OPTICROSS¿ IMAGING CATHETER AND ECCENTRIC CALCIFICATION WAS CONFIRMED. AFTER REMOVAL OF THE IMAGING CATHETER, A 3.5 X 28MM NON-BSC STENT WAS DEPLOYED TO TREAT THE TARGET LESION. THE IMAGING CATHETER WAS ADVANCED TO THE DISTAL SIDE OF THE TARGET LESION TO PERFORM POST-IVUS AND NO RESISTANCE WAS ENCOUNTERED. PULLBACK WAS STARTED FROM THE DISTAL END OF THE DEPLOYED STENT. IT WAS NOTED THAT THE NON-BSC STENT DID NOT EXPAND ENOUGH FROM THE MIDDLE TO DISTAL PART AND THE STENT WAS DEPLOYED FLATLY. THE IMAGING CATHETER WAS ABLE TO PASS THROUGH THE MOST SHARPLY-ANGLED PART OF THE FLAT STENT. AFTER PERFORMING PULLBACK AND UPON REMOVAL OF THE IMAGING CATHETER PROXIMALLY, SEVERE RESISTANCE WAS ENCOUNTERED. IT WAS NOTED THAT THE GUIDE WIRE EXIT PORT OF THE IMAGING CATHETER WAS STUCK WITH THE NON-BSC STENT STRUT. SUBSEQUENTLY, THE PHYSICIAN TRIED TO MOVE THE IMAGING CATHETER DISTALLY AND PERFORMED TORQUE. HOWEVER, THE IMAGING CATHETER COULD NOT BE MOVE AND WAS UNABLE TO BE REMOVED. AN UNSPECIFIED BALLOON CATHETER WAS USED TO PUSH THE GUIDE WIRE EXIT PORT ALONG THE NON-BSC GUIDE WIRE BUT FAILED. THE PHYSICIAN DECIDED TO CUT THE PROXIMAL SHAFT OF THE IMAGING CATHETER. THE IMAGING CORE WAS REMOVED. IT WAS NOTED THAT THE MIDDLE PART OF THE IMAGING CATHETER WAS KINKED. A 0.014 INCH UNSPECIFIED GUIDE WIRE WAS INSERTED THROUGH THE IMAGING CATHETER AND THE IMAGING CATHETER COULD STILL NOT BE REMOVED. THE PHYSICIAN ATTEMPTED TO INSERT A 0.025 INCH UNSPECIFIED GUIDE WIRE TO THE OPPOSITE SIDE OF THE 0.014 INCH UNSPECIFIED GUIDE WIRE. AS THE 0.025 UNSPECIFIED GUIDE WIRE WAS ADVANCED THROUGH THE IMAGING CATHETER, THE GUIDE WIRE PUNCTURED THE IMAGING CATHETER AND PERFORATED THE LMCA. THE PHYSICIAN TRIED TO REMOVE THE IMAGING CATHETER BY ENGAGING A NON-BSC GUIDE CATHETER TO THE VESSEL BUT FAILED. A NON-BSC SNARE WAS USED TO CAPTURE THE GUIDE WIRE EXIT PORT OF THE IMAGING CATHETER. THE CATHETER WAS MOVED PROXIMALLY TOGETHER WITH THE DEPLOYED NON-BSC STENT; HOWEVER, THE PHYSICIAN WAS UNABLE TO PULL THEM BACK WITH THE SNARE. THE PHYSICIAN TRIED TO REMOVE ALL THE SYSTEM. THE IMAGING CATHETER AND THE STENT WERE THEN REMOVED TOGETHER FROM THE PATIENT¿S BODY. ADDITIONALLY, ANOTHER 3.5×25 NON-BSC STENT WAS DEPLOYED TO TREAT THE LESION AND THE VESSEL PERFORATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME IMAGING CATHETER. NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STUCK IN STENT AND VESSEL PERFORATION OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT MAIN CORONARY ARTERY (LMCA) TO PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A NON-BSC GUIDE WIRE WAS ADVANCED TO THE LESION. PRE-DILATATION WAS PERFORMED WITH A 3.0 X 15MM NON-BSC SEMI-COMPLIANT BALLOON. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED USING AN OPTICROSS IMAGING CATHETER AND ECCENTRIC CALCIFICATION WAS CONFIRMED. AFTER REMOVAL OF THE IMAGING CATHETER, A 3.5 X 28MM NON-BSC STENT WAS DEPLOYED TO TREAT THE TARGET LESION. THE IMAGING CATHETER WAS ADVANCED TO THE DISTAL SIDE OF THE TARGET LESION TO PERFORM POST-IVUS AND NO RESISTANCE WAS ENCOUNTERED. PULLBACK WAS STARTED FROM THE DISTAL END OF THE DEPLOYED STENT. IT WAS NOTED THAT THE NON-BSC STENT DID NOT EXPAND ENOUGH FROM THE MIDDLE TO DISTAL PART AND THE STENT WAS DEPLOYED FLATLY. THE IMAGING CATHETER WAS ABLE TO PASS THROUGH THE MOST SHARPLY-ANGLED PART OF THE FLAT STENT. AFTER PERFORMING PULLBACK AND UPON REMOVAL OF THE IMAGING CATHETER PROXIMALLY, SEVERE RESISTANCE WAS ENCOUNTERED. IT WAS NOTED THAT THE GUIDE WIRE EXIT PORT OF THE IMAGING CATHETER WAS STUCK WITH THE NON-BSC STENT STRUT. SUBSEQUENTLY, THE PHYSICIAN TRIED TO MOVE THE IMAGING CATHETER DISTALLY AND PERFORMED TORQUE. HOWEVER, THE IMAGING CATHETER COULD NOT BE MOVE AND WAS UNABLE TO BE REMOVED. AN UNSPECIFIED BALLOON CATHETER WAS USED TO PUSH THE GUIDE WIRE EXIT PORT ALONG THE NON-BSC GUIDE WIRE BUT FAILED. THE PHYSICIAN DECIDED TO CUT THE PROXIMAL SHAFT OF THE IMAGING CATHETER. THE IMAGING CORE WAS REMOVED. IT WAS NOTED THAT THE MIDDLE PART OF THE IMAGING CATHETER WAS KINKED. A 0.014 INCH UNSPECIFIED GUIDE WIRE WAS INSERTED THROUGH THE IMAGING CATHETER AND THE IMAGING CATHETER COULD STILL NOT BE REMOVED. THE PHYSICIAN ATTEMPTED TO INSERT A 0.025 INCH UNSPECIFIED GUIDE WIRE TO THE OPPOSITE SIDE OF THE 0.014 INCH UNSPECIFIED GUIDE WIRE. AS THE 0.025 UNSPECIFIED GUIDE WIRE WAS ADVANCED THROUGH THE IMAGING CATHETER, THE GUIDE WIRE PUNCTURED THE IMAGING CATHETER AND PERFORATED THE LMCA. THE PHYSICIAN TRIED TO REMOVE THE IMAGING CATHETER BY ENGAGING A NON-BSC GUIDE CATHETER TO THE VESSEL BUT FAILED. A NON-BSC SNARE WAS USED TO CAPTURE THE GUIDE WIRE EXIT PORT OF THE IMAGING CATHETER. THE CATHETER WAS MOVED PROXIMALLY TOGETHER WITH THE DEPLOYED NON-BSC STENT; HOWEVER, THE PHYSICIAN WAS UNABLE TO PULL THEM BACK WITH THE SNARE. THE PHYSICIAN TRIED TO REMOVE ALL THE SYSTEM. THE IMAGING CATHETER AND THE STENT WERE THEN REMOVED TOGETHER FROM THE PATIENT'S BODY. ADDITIONALLY, ANOTHER 3.5ײ5 NON-BSC STENT WAS DEPLOYED TO TREAT THE LESION AND THE VESSEL PERFORATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME IMAGING CATHETER. NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654236 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 17092036

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STENT:NOBORI 3.5×28/TERUMO| BALLOON CATHETER:CATENACCIO2 3.0×15/JIMRO| GUIDEWIRE:SOFT/ASAHI INTECC