BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYHESIVE PATIENT RETURN ELECTRODE

    MDR report key: 1832616 · Received September 13, 2010

    Report

    Report Number
    3005099803-2010-03864
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEI
    PMA / PMN Number
    K822572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND DISCOLORATION AT THE TOP CENTER OF THE PAD. NO OTHER PHYSICAL DEFECTS WERE OBSERVED. ADDITIONALLY, THE WIRES WERE SECURELY ATTACHED AND THE PAD PASSED A CONTINUITY TEST. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT OF PAD DISCOLORATION. THIS EVENT IS CONSIDERED A USER PREFERENCE ISSUE. THE OEM INVESTIGATOR NOTED, "ON OCCASION, THE VALLEYLAB POLYHESIVE CONDUCTIVE ADHESIVE MAY HAVE AREAS OR SPOTS OF DISCOLORATION WITHIN THE GEL. THIS IS OF NO CLINICAL CONSEQUENCE. THE SMALL AREAS OF DISCOLORATION ON THE PADS ARE DUE TO TARNISH ON THE SURFACE OF THE CONDUCTIVE FOIL BENEATH THE POLYHESIVE MATERIAL. THE DISCOLORATION IS THE RESULT OF THE AQUEOUS ENVIRONMENT PROVIDED BY THE POLYHESIVE IN CONTACT WITH THE METAL FOIL. PAST INVESTIGATIONS HAVE DEMONSTRATED THAT DISCOLORATION DOES NOT AFFECT THE INTEGRITY OR SAFE USE OF THE PRODUCT." THUS, THE ISSUE OF PAD DISCOLORATION IS NOT CONSIDERED A MDR REPORTABLE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PATIENT RETURN GROUNDING PAD WAS USED DURING A LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, WHILE PREPARING FOR THE PROCEDURE, GROUNDING PAD DISCOLORATION WAS IDENTIFIED. THE PROCEDURE WAS COMPLETED WITH ANOTHER PATIENT RETURN GROUNDING PAD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PATIENT RETURN GROUNDING PAD WAS USED DURING A LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, WHILE PREPARING FOR THE PROCEDURE, GROUNDING PAD DISCOLORATION WAS IDENTIFIED. THE PROCEDURE WAS COMPLETED WITH ANOTHER PATIENT RETURN GROUNDING PAD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYHESIVE PATIENT RETURN ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - MARLBOROUGH M001262191 149553

    Patients

    Seq Age Sex Outcome Treatment
    1