BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NRG TRANSSEPTAL NEEDLE

    MDR report key: 5151575 · Received October 15, 2015

    Report

    Report Number
    9710452-2015-00029
    Event Type
    Injury
    Date Received
    October 15, 2015
    Report Date
    November 30, 2015
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DXF
    PMA / PMN Number
    K073326
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO SUSPECTED DEVICE FAILURE. PERFORATION IS AN INHERENT RISK TO THIS TYPE OF PROCEDURE AND IS IDENTIFIED IN THE DEVICE INSTRUCTIONS FOR USE. THE PRIMARY AUTHOR OF THE ARTICLE WAS CONTACTED BY THE MANUFACTURER FOR ADDITIONAL INFORMATION RELATED TO THE REPORTED COMPLICATIONS IN THE ARTICLE. THE AUTHOR INDICATED THAT THE BAYLIS NRG TRANSSEPTAL NEEDLE WAS NOT RELATED TO ANY OF THE REPORTED COMPLICATIONS.

    Additional Manufacturer Narrative · 1

    THERE IS NO SUSPECTED DEVICE FAILURE. PERFORATION IS AN INHERENT RISK TO THIS TYPE OF PROCEDURE AND IS IDENTIFIED IN THE DEVICE INSTRUCTIONS FOR USE. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    DURING A PERIODIC REVIEW OF PUBLISHED LITERATURE BY THE MANUFACTURER, BAYLIS MEDICAL DEVICES WERE IDENTIFIED AMONG SEVERAL OTHER MANUFACTURERS' DEVICES AS HAVING BEEN USED IN PROCEDURES WITH REPORTED COMPLICATIONS. THERE IS NO EVIDENCE TO SUGGEST THE BAYLIS MEDICAL DEVICES CAUSED OR CONTRIBUTED TO THE REPORTED COMPLICATIONS. HOWEVER, AS THE BAYLIS DEVICES WERE AMONG THE SEVERAL DEVICES USED IN THE PROCEDURES, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT. ARTICLE REFERENCE: WINKLE, R. A., MEAD, R. H., ENGEL, G., KONG, M. H., & PATRAWALA, R. A. (2014). PERI-PROCEDURAL INTERRUPTED ORAL ANTICOAGULATION FOR ATRIAL FIBRILLATION ABLATION: COMPARISON OF ASPIRIN, WARFARIN, DABIGATRAN, AND RIVAROXABAN. EUROPACE, 16, 1443-9. AS PER THIS ARTICLE, "THERE WERE (B)(4) (0.51%) PERICARDIAL TAMPONADES. EIGHT WERE TREATED WITH EMERGENT PERICARDIOCENTESIS AND TWO WITH SURGICAL DRAINAGE. TWO UNDERWENT SEMIELECTIVE PERICARDIOCENTESIS POST-HOSPITAL DISCHARGE... GROIN COMPLICATIONS OCCURRED IN (B)(4) (0.51%) ABLATIONS. THIS INCLUDED NINE GROIN PSEUDOANEURYSMS OR AV FISTULAE, SIX TREATED WITH ULTRASOUND-GUIDED COMPRESSION OR LOCAL THROMBIN INJECTIONS AND THREE REQUIRING SURGICAL REPAIR. TWO GROIN HAEMATOMAS AND ONE RETROPERITONEAL BLEED REQUIRED TRANSFUSION...THERE WERE THREE MAJOR NON-GROIN BLEEDING COMPLICATIONS: ONE TRAUMATIC URINARY CATHETER INSERTION REQUIRING BLOOD TRANSFUSION IN A WARFARIN PATIENT; ONE INTUBATION-RELATED TONGUE HAEMATOMA; AND ONE RUPTURED CEREBRAL ANEURYSM ON DAY 7 POST-ABLATION IN A RIVAROXABAN PATIENT WHO HAD ALSO BEEN ON RIVAROXABAN PRE-ABLATION. AFTER A FAILED CATHETER ATTEMPT TO SEAL THE ANEURYSM, THE PATIENT UNDERWENT SURGICAL TREATMENT AND EXPIRED ON DAY 31 POST-ABLATION. ONE PATIENT ON DABIGATRAN HAD A SMALL PULMONARY EMBOLUS SEVERAL WEEKS POST-ABLATION WHICH RESOLVED WITHOUT SEQUELAE. ONLY (B)(4) (0.21%) ABLATIONS WERE ASSOCIATED WITH A COMPLICATION REQUIRING BLOOD TRANSFUSION. THERE WERE TWO INTRAPROCEDURAL STROKES (0.086%) AND NO TIA'S IN THE FIRST 48 H POST-ABLATION. ONE STROKE RESOLVED OVER TIME AND THE OTHER LEFT A RESIDUAL DEFICIT. THREE ADDITIONAL STROKES (0.13%)-ALL RESOLVED WITHOUT PERMANENT DEFICIT-AND TWO TIAS (0.086%) OCCURRED FROM 48 H TO 30 DAYS POST-ABLATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684315 NRG TRANSSEPTAL NEEDLE RF TRANSSEPTAL NEEDLE DXF BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R