BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMMETRY 40 OVER-THE-WIRE BALLOON DILATATION CATHETER

    MDR report key: 1991884 · Received February 15, 2011

    Report

    Report Number
    2134265-2011-00199
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS WITH AN UNKNOWN SIZED INTRODUCER SHEATH. TRACES OF BLOOD WERE PRESENT INSIDE THE SHEATH. AN EXAMINATION OF THE RETURNED DEVICE NOTED THE DISTAL TIP AND THE BALLOON WITH BOTH THE RO MARKERBANDS HAD DETACHED FROM THE PROXIMAL BALLOON BOND AND WERE NOT RETURNED. THE AREA OF THE DEVICE DISTAL TO THE PROXIMAL BALLOON BOND WAS SEVERELY STRETCHED. THE PROXIMAL BALLOON BOND WAS NOT INTACT. SEVERAL KINKS WERE NOTED ALONG THE LENGTH OF THE SHAFT. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS USER RELATED AS THE DFU STATES "RATED BURST PRESSURE SHOULD NOT BE EXCEEDED. INFLATION IN EXCESS OF RATED BURST PRESSURE MAY CAUSE THE BALLOON TO RUPTURE." (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE; A BALLOON RUPTURE, BALLOON AND TIP DETACHMENT, AND WITHDRAWAL DIFFICULTIES OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH ANOTHER MANUFACTURERS' 6F 3CM INTRODUCER SHEATH VIA THE LEFT BRACHIAL USING A RETROGRADE APPROACH. THE PHYSICIAN WAS TREATING A 90% STENOSED LESION LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTEBRACHIUM. ANOTHER MANUFACTURERS' 180CM GUIDE WIRE WAS INSERTED AND THIS SYMMETRY BALLOON CATHETER WAS ADVANCED TO THE LESION WITHOUT RESISTANCE. ONCE TO THE LESION, TWO INFLATIONS WERE MADE TO 20 ATMS EACH. THE SYMMETRY BALLOON CATHETER WAS THEN MOVED PROXIMAL AND A THIRD INFLATION WAS MADE; HOWEVER, THE BALLOON RUPTURED AT 20 ATMS. SEVERE RESISTANCE WAS ENCOUNTERED WHILE TRYING TO WITHDRAW THE SYMMETRY CATHETER THROUGH THE INTRODUCER SHEATH CAUSING THE SHUNT TO BECOME ELONGATED. THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON CATHETER AND THE INTRODUCER SHEATH TOGETHER; HOWEVER, THE BALLOON AND TIP SECTION OF THE SYMMETRY DETACHED IN THIS ATTEMPT. THE BALLOON AND TIP SECTION REMAIN IN THE SHUNT. THE PHYSICIAN DECIDED TO NOT RETRIEVE THE DETACHED PIECES AND CLOSED THE SHUNT. THE PHYSICIAN BELIEVES THE PATIENT IS NOT AT RISK. A NEW GRAFT WAS CREATED AT THE BRACHIAL SITE AND HEMODIALYSIS HAS BEEN PERFORMED WITHOUT COMPLICATIONS. THERE WERE NO FURTHER REPORTED PATIENT COMPLICATIONS AND THE PATIENT STATUS IS GOOD. THIS PRODUCT IS ONLY OUS APPROVED, BUT IT IS SIMILAR TO AN APPROVED U.S. DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE; A BALLOON RUPTURE, BALLOON AND TIP DETACHMENT, AND WITHDRAWAL DIFFICULTIES OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH ANOTHER MANUFACTURERS' 6F 3CM INTRODUCER SHEATH VIA THE LEFT BRACHIAL USING A RETROGRADE APPROACH. THE PHYSICIAN WAS TREATING A 90% STENOSED LESION LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTEBRACHIUM. ANOTHER MANUFACTURERS' 180CM GUIDE WIRE WAS INSERTED AND THIS SYMMETRY BALLOON CATHETER WAS ADVANCED TO THE LESION WITHOUT RESISTANCE. ONCE TO THE LESION, TWO INFLATIONS WERE MADE TO 20ATMS EACH. THE SYMMETRY BALLOON CATHETER WAS THEN MOVED PROXIMAL AND A THIRD INFLATION WAS MADE; HOWEVER, THE BALLOON RUPTURED AT 20ATMS. SEVERE RESISTANCE WAS ENCOUNTERED WHILE TRYING TO WITHDRAW THE SYMMETRY CATHETER THROUGH THE INTRODUCER SHEATH CAUSING THE SHUNT TO BECOME ELONGATED. THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON CATHETER AND THE INTRODUCER SHEATH TOGETHER; HOWEVER, THE BALLOON AND TIP SECTION OF THE SYMMETRY DETACHED IN THIS ATTEMPT. THE BALLOON AND TIP SECTION REMAIN IN THE SHUNT. THE PHYSICIAN DECIDED TO NOT RETRIEVE THE DETACHED PIECES AND CLOSED THE SHUNT. THE PHYSICIAN BELIEVES THE PATIENT IS NOT AT RISK. A NEW GRAFT WAS CREATED AT THE BRACHIAL SITE AND HEMODIALYSIS HAS BEEN PERFORMED WITHOUT COMPLICATIONS. THERE WERE NO FURTHER REPORTED PATIENT COMPLICATIONS AND THE PATIENT STATUS IS GOOD. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMMETRY 40 OVER-THE-WIRE BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H7493918750400 13833268

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INFLATION DEVICE: KANEKA| INTRODUCER SHEATH: 6F MOSQUITO 3CM| GUIDE WIRE: 0.016 RADIFOCUS 180CM