BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMMETRY¿

    MDR report key: 3013320 · Received March 20, 2013

    Report

    Report Number
    2134265-2013-01546
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K953602
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: INITIAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE BALLOON MATERIAL WAS TORN CIRCUMFERENTIALLY AT THE PROXIMAL TRANSITION ZONE. IT WAS NOTED THAT THE DISTAL BALLOON SLEEVE HAD DETACHED FROM THE SHAFT. A PARTIAL CIRCUMFERENTIAL TEAR WAS NOTED AT THE DISTAL PORTION OF THE BALLOON. IT WAS NOTED THAT THE PROXIMAL BALLOON SLEEVE WAS ATTACHED TO THE SHAFT. EXAMINATION OF THE BOND SITE ON THE DISTAL TIP OF THE CATHETER CONFIRMED THAT THERE WAS SUFFICIENT UV GLUE APPLIED TO BOTH THE BALLOON AND THE TIP BOND LOCATION. THE CATHETER SURFACE WAS ADEQUATELY PREPARED FOR BONDING AS THERE WAS EVIDENCE OF MICRO BLAST UNDER THE CURED GLUE. CLOSER EXAMINATION OF THE BOND SITE REVEALED EVIDENCE THAT THE BALLOON WAS CURED TO THE TIP. THERE WAS AN IMPRESSION OF THE BALLOON SLEEVE IN THE GLUE ALONG WITH TRACE OF BALLOON MATERIAL. MICROSCOPIC EXAMINATION OF THE BALLOON SLEEVE INDICATES THAT THE BALLOON SLEEVE INNER SURFACE WAS PREPARED FOR BONDING PROCESS AS THE MATERIAL HAD BEEN ROUGHENED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE LESION WAS MODERATELY TORTUOUS AND NON CALCIFIED AND LOCATED IN THE RIGHT INFRA-AXILLARY VEIN. A NON BSC 5FR SHEATH WAS USED. A NON BSC 0.018 INCH GUIDE WIRE CROSSED THE LESION. THE (B)(4) BALLOON CATHETER WAS ADVANCED TO THE LESION AND INFLATED TO TEN ATMOSPHERES FOR THIRTY SECONDS ON THE FIRST INFLATION. WHEN THEY DEFLATED THE BALLOON, THEY NOTICED THAT BLOOD WAS INSIDE THE INFLATOR AND THE BALLOON HAD BEEN RUPTURED. THE BALLOON WAS DEFLATED ALREADY AND THE BALLOON WAS PULLED BACK INTO THE SHEATH. THERE WAS NO RESISTANCE DURING THE REMOVAL OF THIS DEVICE. THEY NOTICED THAT A PART OF THE BALLOON WAS NOT REMOVED FROM THE PATIENT. IT WAS NOTICED THAT THE BALLOON PART WAS AT ANASTOMOSIS AREA UNDER FLUOROSCOPIC GUIDANCE. THEY HELD THE AREA FROM THE OUTSIDE THE PATIENT AND COMPRESSED THE RIGHT INFRA-AXILLARY VEIN TO PREVENT THE MOVING OF THE BALLOON TO THE MIDDLE OF THE VESSEL. THERE WERE NO OTHER FRAGMENTS INSIDE THE PATIENT, AND THEY PERFORMED SURGERY IN THE ANGIOGRAPHY ROOM TO RETRIEVE THE FRAGMENT AT ANASTOMOSIS AREA. THEY CUT ABOUT 5CM AT 10CM FROM THE ANASTOMOSIS AREA. THEY ADVANCED THE FORCEPS FROM THE INCISION AND RETRIEVED THE BALLOON PART. TO PREVENT THE INFECTIONS THE PATIENT WAS HOSPITALIZED FOR ONE WEEK. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO OTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE LESION WAS MODERATELY TORTUOUS AND NON CALCIFIED AND LOCATED IN THE RIGHT INFRA-AXILLARY VEIN. A NON BSC 5FR SHEATH WAS USED. A NON BSC 0.018 INCH GUIDE WIRE CROSSED THE LESION. THE SV/6.0-4/4T/90 BALLOON CATHETER WAS ADVANCED TO THE LESION AND INFLATED TO TEN ATMOSPHERES FOR THIRTY SECONDS ON THE FIRST INFLATION. WHEN THEY DEFLATED THE BALLOON, THEY NOTICED THAT BLOOD WAS INSIDE THE INFLATOR AND THE BALLOON HAD BEEN RUPTURED. THE BALLOON WAS DEFLATED ALREADY AND THE BALLOON WAS PULLED BACK INTO THE SHEATH. THERE WAS NO RESISTANCE DURING THE REMOVAL OF THIS DEVICE. THEY NOTICED THAT A PART OF THE BALLOON WAS NOT REMOVED FROM THE PATIENT. IT WAS NOTICED THAT THE BALLOON PART WAS AT ANASTOMOSIS AREA UNDER FLUOROSCOPIC GUIDANCE. THEY HELD THE AREA FROM THE OUTSIDE THE PATIENT AND COMPRESSED THE RIGHT INFRA-AXILLARY VEIN TO PREVENT THE MOVING OF THE BALLOON TO THE MIDDLE OF THE VESSEL. THERE WERE NO OTHER FRAGMENTS INSIDE THE PATIENT, AND THEY PERFORMED SURGERY IN THE ANGIOGRAPHY ROOM TO RETRIEVE THE FRAGMENT AT ANASTOMOSIS AREA. THEY CUT ABOUT 5CM AT 10CM FROM THE ANASTOMOSIS AREA. THEY ADVANCED THE FORCEPS FROM THE INCISION AND RETRIEVED THE BALLOON PART. TO PREVENT THE INFECTIONS THE PATIENT WAS HOSPITALIZED FOR ONE WEEK. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO OTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115748 SYMMETRY¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY M001103340 0015553999

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention 0.018 INCH 150CM HANAKO GUIDEWIRE| 5FR VAIVT ACE 3CM SHEATH| 0.018" 150CM GUIDE WIRE (HANAKO)| 5FR SHEATH VAIVT ACE 3CM/MEDIKIT