BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPIRA NC RX PTCA DILATATION CATHETER

    MDR report key: 6673077 · Received June 28, 2017

    Report

    Report Number
    3004036480-2017-00003
    Event Type
    Malfunction
    Date Received
    June 28, 2017
    Date of Event
    June 13, 2017
    Report Date
    July 13, 2017
    Manufacturer
    CREGANNA MEDICAL ALSO D/B/A CREGANNA-TACTX MEDICAL
    Product Code
    LOX
    PMA / PMN Number
    K110133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP MDR IS TO GIVE AN UPDATE ON THE INVESTIGATION FINDINGS BY CREGANNA MEDICAL IN RELATION TO THIS EVENT AS FOLLOWS: THE INITIAL COMPLAINT RECEIVED REPORTED THAT 'DISTAL THIRD OF THE BALLOON DID NOT DEFLATE AND THE DISTAL PORTION OF THE SHAFT WAS DAMAGED. DOCTOR REPORTED SALES REP. THAT THERE WAS NO CLINICAL IMPACT ON THE PATIENT AND THAT IT IS THE FIRST TIME THAT THIS OCCURS WITH HIM.' NO ADDITIONAL INFORMATION IN RELATION TO THE COMPLAINT EVENT WAS RECEIVED. THIS COMPLAINT IS MDR REPORTABLE BASED ON PRODUCT MALFUNCTION PRECEDENCE OF 'BALLOON - DEFLATION DIFFICULTY' FOR THE EMPIRA DEVICE. THE COMPLAINT DEVICE WAS NOT RETURNED FOR REVIEW AT THE TIME THIS INVESTIGATION REPORT WAS COMPLETED. AS THE DEVICE WAS NOT AVAILABLE FOR INVESTIGATION AND EXAMINATION, IT WAS THEREFORE NOT POSSIBLE TO CARRY OUT ANY DIMENSIONAL, FUNCTIONAL, VISUAL OR MICROSCOPIC EXAMINATION ON THE DEVICE. THEREFORE THE REPORTED CLASSIFICATIONS OF 'BALLOON - DEFLATION DIFFICULTY' COULD NOT BE CONFIRMED. BASED ON A REVIEW OF THE RISK DOCUMENTATION AND INFORMATION AVAILABLE, NO UPDATES ARE REQUIRED TO THE RISK DOCUMENTATION FOR THE EMPIRA DEVICE. THERE IS NO INDICATION OF A POTENTIAL PROCESSING OR DESIGN FAILURE ASSOCIATED WITH THIS COMPLAINT. THE BATCH NUMBER OF THE COMPLAINT DEVICE IS UNKNOWN AT THIS TIME. AS THE BATCH NUMBER IS UNKNOWN, A REVIEW ON TREND DATA COULD NOT BE COMPLETED. A REQUEST HAS BEEN INITIATED TO RETRIEVE THE RELEVANT BATCH NUMBER HOWEVER THIS INFORMATION HAS NOT BEEN PROVIDED. SHOULD THE BATCH NUMBER BECOME AVAILABLE AT A LATER DATE THEN THIS COMPLAINT WILL BE REOPENED AND UPDATED ACCORDINGLY. A REQUEST FOR A SHIP HISTORY TO BE COMPLETED HAS BEEN INITIATED HOWEVER THIS INFORMATION WAS NOT AVAILABLE AT THE TIME THIS INVESTIGATION REPORT WAS COMPLETED. FROM THE INFORMATION AVAILABLE, THERE IS NO EVIDENCE PRESENT TO INDICATE THAT THE DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE/PRODUCT LABEL. PRODUCT WAS NOT RETURNED FOR REVIEW AT THE TIME THIS REPORT WAS COMPLETED. THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION AND EXAMINATION. IT WAS THEREFORE NOT POSSIBLE TO CARRY OUT ANY DIMENSIONAL, FUNCTIONAL, VISUAL OR MICROSCOPIC EXAMINATION ON THE DEVICE. THEREFORE THE AS REPORTED CLASSIFICATIONS OF (BALLOON - DEFLATION DIFFICULTY) CANNOT BE DETERMINED. THE PROBABLE ROOT-CAUSE CLASSIFICATION ASSIGNED TO THIS COMPLAINT IS 'UNDETERMINABLE. THE DEFINITION OF 'UNDETERMINABLE' PER CSOP0058 IS: 'REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILS TO INDICATE A ROOT CAUSE OR PROBABLE ROOT CAUSE.' BASED ON THE ABOVE CONCLUSION, NO FURTHER ESCALATION OR CORRECTIVE ACTION IS REQUIRED AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR THESE COMPLAINT TYPES. IF ANY ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, A FOLLOW UP MDR WILL BE SENT. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. A FOLLOW-UP MDR REPORT WILL BE SUBMITTED WITH THE INVESTIGATION FINDINGS. DEVICE TO BE RETURNED - NOT YET RECEIVED.

    Description of Event or Problem · 1

    THE FOLLOWING INITIAL COMPLAINT DESCRIPTION WAS RECEIVED: "DISTAL THIRD OF THE BALLOON DID NOT DEFLATE AND THE DISTAL PORTION OF THE SHAFT WAS DAMAGED. DOCTOR REPORTED TO SALES REP. THAT THERE WAS NO CLINICAL IMPACT ON THE PATIENT AND THAT IT IS THE FIRST TIME THAT THIS OCCURS WITH HIM."

    Description of Event or Problem · 1

    COMPLAINT DESCRIPTION RECEIVED: "DISTAL THIRD OF THE BALLOON DID NOT DEFLATE AND THE DISTAL PORTION OF THE SHAFT WAS DAMAGED. DOCTOR REPORTED TO SALES REP. THAT THERE WAS NO CLINICAL IMPACT ON THE PATIENT AND THAT IT IS THE FIRST TIME THAT THIS OCCURS WITH HIM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454811 EMPIRA NC RX PTCA DILATATION CATHETER PTCA CATHETER LOX CREGANNA MEDICAL ALSO D/B/A CREGANNA-TACTX MEDICAL 75R20300N UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1