BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 3831665 · Received May 26, 2014

    Report

    Report Number
    3002648230-2014-00086
    Event Type
    Injury
    Date Received
    May 26, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 29, 2014
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION; IT WAS DISCARDED AFTER THE PROCEDURE. BIN FILES AND FAILURE FILES FROM THE DATE OF EVENT WERE REVIEWED AND DID NOT SHOW ANY SYSTEM NOTICE MESSAGES. BIN FILES SHOWED THAT AT LEAST 20 INJECTIONS WERE PERFORMED WITH THE CATHETER AND ALSO SHOWED A TEMPERATURE SPIKE AT 36 SECONDS INTO THE SECOND INJECTION. THERE WAS NO INDICATION OF PRODUCT MALFUNCTION.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION; IT WAS DISCARDED AFTER THE PROCEDURE. THERE WAS NO INDICATION OF PRODUCT MALFUNCTION. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT, POST CRYOABLATION PROCEDURE, THE PATIENT HAD A DEEP PENETRATING ESOPHAGEAL ULCER REQUIRING SURGICAL INTERVENTION. CRYOABLATION PROCEDURE PERFORMED ON (B)(6) 2014. A FEW DAYS POST PROCEDURE, THE PATIENT PRESENTED TO ER WITH HEMOPTYSIS. ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED ON (B)(6) 2014: 1 X 2 CM ROUND APPEARING DEEP ULCER IN MID-ESOPHAGUS AT APPROXIMATELY 30 CM FROM INCISORS. MILD ANTRAL GASTRITIS. CT ANGIOGRAPHY OF THE CHEST WITH IV CONTRAST PERFORMED: INCREASED ESOPHAGEAL WALL THICKENING AND INFILTRATION OF THE ADJACENT PERIES OPHAGEAL FAT. BILATERAL PLEURAL EFFUSIONS. PATCHY AREAS OF ATELECTASIS OR PNEUMONITIS. HIATAL HERNIA. THE FINDINGS APPEARED TO BE SOMEWHAT ASYMMETRIC TOWARD THE RIGHT ANTERIORLY WITHOUT EVIDENCE OF PERFORATION OR FISTULA. ORAL CONTRAST WAS GIVEN AND NO DEFINITE FISTULIZATION WAS SHOWN. SURGICAL PROCEDURE PERFORMED ON (B)(6) 2014: RIGHT THORACOTOMY WITH INTERCOSTAL MUSCLE FLAP REPAIR OF DEEP PENETRATING ESOPHAGEAL ULCER. DRAINAGE OF RIGHT PLEURAL EFFUSION. THE BACK OF THE LEFT ATRIUM WAS INSPECTED AND ALTHOUGH THERE WAS CLEARLY INJURY TO THE LEFT ATRIUM, THERE WAS NO FULL-THICKNESS EROSION AND NO SUTURING OF THE LEFT ATRIUM WAS REQUIRED. ESOPHAGRAM PERFORMED ON (B)(6) 2014: SINGLE CONTRAST GASTROGRAFIN ESOPHAGRAM DEMONSTRATED NO EVIDENCE OF EXTRAVASATION TO SUGGEST ESOPHAGEAL PERFORATION. MILD ESOPHAGEAL DYSMOTILITY.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT, POST CRYOABLATION PROCEDURE, THE PATIENT HAD A DEEP PENETRATING ESOPHAGEAL ULCER WHICH REQUIRED SURGICAL CONSULTATION. CRYOABLATION PROCEDURE PERFORMED (B)(6) 2014. A FEW DAYS POST PROCEDURE, THE PATIENT PRESENTED TO ER WITH HEMOPTYSIS. AS PER SURGEON CONSULT NOTE ON (B)(6) 2014, ESOPHAGOGASTRODUODENOSCOPY (EGD) NOTED 1 X 2 CM ROUND APPEARING DEEP ULCER IN MID-ESOPHAGUS AT APPROXIMATELY 30 CM FROM INCISORS. THE FINDINGS APPEARED TO BE SOMEWHAT ASYMMETRIC TOWARD THE RIGHT ANTERIORLY WITHOUT EVIDENCE OF PERFORATION OR FISTULA. CT OF CHEST NOTED SOME WALL THICKENING AROUND THE ESOPHAGUS. ORAL CONTRAST WAS GIVEN AND NO DEFINITE FISTULIZATION WAS SHOWN. AS PER SURGEON'S DESCRIPTION OF PROCEDURE ON (B)(6) 2014, THE BACK OF THE LEFT ATRIUM WAS INSPECTED AND ALTHOUGH THERE WAS CLEARLY INJURY TO THE LEFT ATRIUM, THERE WAS NO FULL-THICKNESS EROSION AND NO SUTURING OF THE LEFT ATRIUM WAS REQUIRED. ESOPHOGRAM PERFORMED (B)(6) 2014; SINGLE CONTRAST GASTROGRAFIN ESOPHAGEAL DEMONSTRATED NO EVIDENCE OF EXTRAVASATION TO SUGGEST ESOPHAGEAL PERFORATION. MILD ESOPHAGEAL DYSMOTILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309962 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284 94223

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| R