BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET

    MDR report key: 6559680 · Received May 11, 2017

    Report

    Report Number
    2522007-2017-00017
    Event Type
    Injury
    Date Received
    May 11, 2017
    Date of Event
    April 4, 2017
    Report Date
    December 21, 2017
    Manufacturer
    COOK VASCULAR INC
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510K- K142301. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PER THE FACILITY: "PATIENT SURVIVED AND IS DOING VERY WELL." INVESTIGATION  EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU), TRENDS, AND A RISK ASSESSMENT WERE CONDUCTED DURING THE INVESTIGATION, AND NO ISSUES WERE FOUND RELATED TO THE REPORTED ISSUE. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATION COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE COMPLAINANT DEVICE LOT NUMBER IS UNKNOWN. THUS, A REVIEW OF THE DEVICE HISTORY RECORD, NONCONFORMANCE HISTORY, AND RELATED PRODUCT COMPLAINTS QUERY COULD NOT BE CONDUCTED. THE IFU WAS REVIEWED AND A LIST OF POTENTIAL ADVERSE EVENT IS PROVIDED AND INCLUDES: LACERATION OR TEARING OF VASCULAR STRUCTURES OR THE MYOCARDIUM, AMONG OTHER ADVERSE EVENTS THAT ARE LISTED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING A LEAD EXTRACTION PROCEDURE ON A MALE PATIENT. THE PATIENT HAD PREVIOUSLY IMPLANTED LEADS. TWO LEADS ON RIGHT SIDE (IMPLANTED IN 1988 IN (B)(6)). THERE ARE NO RECORDS ON THESE LEADS. ADDITIONALLY, THE PATIENT HAD 4 LEADS IMPLANTED ON LEFT SIDE IN THE YEAR 2012. THE PHYSICIAN EXTRACTED LEFT SIDE LEADS FIRST WITH A LASER SHEATH WITHOUT ANY ISSUES. THE PHYSICIAN COULD NOT GET PAST THE BINDING SITE AT INNOMINATE VEIN ON THE RIGHT-SIDE WITH EITHER THE LASER OR TIGHT-RAIL DEVICE FROM DIFFERENT MANUFACTURER; THEREFORE A LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET WAS USED TO COMPLETE THE PROCEDURE. IT WAS FURTHER REPORTED BY THE PHYSICIAN THAT WHILE NAVIGATING WITH THE LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET THROUGH SUPERIOR VENA CAVA (SVC), A TEAR OCCURRED WHICH RESULTED IN A BLOOD PRESSURE DROP IN THE PATIENT. THE PHYSICIAN PERFORMED A TRANSESOPHAGEAL ECHOCARDIOGRAM(TEE) BY INSERTING A PROBE WITH A TRANSDUCER DOWN THE ESOPHAGUS. THE PHYSICIAN FOUND THAT THE TEAR OCCURRED WHERE THE CALCIFIED BINDING WAS PRESENT IN SVC AND THAT THE CALCIFICATIONS PENETRATED THE SVC WALL. THE LEAD TOOK AN ACUTE ANGLE FROM RIGHT SIDE INTO SVC, WHICH CAUSED DIFFICULTY IN NAVIGATING THE DEVICE. INJURY WAS MOST LIKELY UNAVOIDABLE GIVEN CALCIFICATIONS PENETRATING THE SVC WALL. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENTS BODY. PATIENT REQUIRED A STERNOTOMY TO REPAIR THE SVC TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343254 LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK VASCULAR INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention 14 F LASER SHEATH, 11 F TIGHT RAIL (SPECTRANETICS)