BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2CM PERIPHERAL CUTTING BALLOON®

    MDR report key: 5034809 · Received August 27, 2015

    Report

    Report Number
    2134265-2015-05637
    Event Type
    Injury
    Date Received
    August 27, 2015
    Date of Event
    July 30, 2015
    Report Date
    July 30, 2015
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K070951
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME - CORRECTED FROM "SMALL PERIPHERAL CUTTING BALLOON" TO "2CM PERIPHERAL CUTTING BALLOON®." COMMON DEVICE NAME - CORRECTED FROM "CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS" TO "CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA." PRODUCT CODE - CORRECTED FROM NWX TO LIT. UPN - CORRECTED FROM M001BPM2015140F0 TO M001PCB6020900. CATALOG/MODEL # - CORRECTED FROM BPM2015140F TO PCB602090. DEVICE EVALUATED BY MFR: DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON WAS NOT FOLDED WHICH INDICATES THAT THE BALLOON WAS SUBJECTED TO POSITIVE PRESSURE. IT WAS NOTED THAT THE BALLOON WAS RETURNED FULLY DEFLATED. THE RETURNED DEVICE WAS ATTACHED TO AN INFLATION DEVICE AND POSITIVE PRESSURE WAS APPLIED TO INFLATE THE BALLOON. THE BALLOON WAS ABLE TO BE INFLATED TO ITS RATED BURST PRESSURE. THE BALLOON INFLATED AND DEFLATED SUCCESSFULLY. INFLATION AND DEFLATION WAS PERFORMED THREE TIMES GIVING AN AVERAGE DEFLATION TIME OF 7 SECONDS. DEFLATION TIME FOR PCB 2CM BALLOONS IS LESS THAN OR EQUAL TO 30 SECONDS. THE INFLATION DEVICE WAS VERIFIED BEFORE AND AFTER USE USING A CALIBRATED PRESSURE GAUGE. THE DEFLATION TIME WAS RECORDED USING THE DIGITAL TIMER. ALL BLADES WERE PRESENT AND FULLY BONDED TO THE BALLOON SURFACE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE AND THE PATIENT SUSTAINED A LACERATION. THE TARGET LESION WAS AN A-V FISTULA LOCATED IN THE UPPER CEPHALIC OF THE PATIENT'S LEFT ARM. A 2.00MM/1.5CM/140CM SMALL PERIPHERAL CUTTING BALLOON MONORAIL WAS USED TO TREAT THE TARGET LESION; HOWEVER, THE BALLOON DID NOT DEFLATE PROPERLY. DURING WITHDRAWAL, ONE OF THE ARTHROTOMES ON THE BALLOON SLICED THE NON BSC SHEATH AND THE PATIENT SUSTAINED A SMALL LACERATION AT THE SHEATH ENTRY SITE. THE PHYSICIAN APPLIED PRESSURE MANUALLY AT THE SHEATH INSERTION SITE FOR 30-40 MINUTES. BEFORE THE PROCEDURE WAS ENDED, A FINAL ANGIOGRAM REVEALED THE FISTULA WAS OK. NO FURTHER BLEEDING OR HEMATOMA WAS NOTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE AND THE PATIENT SUSTAINED A LACERATION. THE TARGET LESION WAS AN A-V FISTULA LOCATED IN THE UPPER CEPHALIC OF THE PATIENT'S LEFT ARM. A 2.00MM/1.5CM/140CM SMALL PERIPHERAL CUTTING BALLOON¿ MONORAIL WAS USED TO TREAT THE TARGET LESION; HOWEVER, THE BALLOON DID NOT DEFLATE PROPERLY. DURING WITHDRAWAL, ONE OF THE ATHEROTOMES ON THE BALLOON SLICED THE NON BSC SHEATH AND THE PATIENT SUSTAINED A SMALL LACERATION AT THE SHEATH ENTRY SITE. THE PHYSICIAN APPLIED PRESSURE MANUALLY AT THE SHEATH INSERTION SITE FOR 30-40 MINUTES. BEFORE THE PROCEDURE WAS ENDED, A FINAL ANGIOGRAM REVEALED THE FISTULA WAS OK. NO FURTHER BLEEDING OR HEMATOMA WAS NOTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567203 2CM PERIPHERAL CUTTING BALLOON® CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA LIT BOSTON SCIENTIFIC - GALWAY M001PCB6020900

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention