BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1820425 · Received August 30, 2010

    Report

    Report Number
    2939301-2010-07355
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Report Date
    August 23, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE PCB CONTAMINATION. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE STENT BECAME CAUGHT ON THE STRUT OF THE 1ST CYPHER. THE PHYSICIAN ALSO CONFIRMED THE STENT TO BE FLARED PROXIMALLY. THE PROCEDURE WAS AN EMERGENT CASE DUE TO ACS. PRE-DILATION WAS PERFORMED WITH A BALLOON (LAOH10/13MM) AND THE 1ST CYPHER SELECT+ 3.0 X 13MM WAS INITIALLY IMPLANTED AT THE OSTIUM OF THE PROX-RCA ((B)(4)). THEN A 2ND CYPHER SELECT+ 3.0 X 28MM WAS BEING DELIVERED TO THE DISTAL END OF THE TARGET LESION, BUT THE 2ND CYPHER SELECT+ BECAME CAUGHT ON THE STRUT OF THE 1ST CYPHER SELECT+ AND IT WOULD NOT ADVANCE FURTHER. THEREFORE DOUBLE WIRE TECHNIQUE WAS CONDUCTED AND THE GUIDING CATHETER WAS DEEP ENGAGED, AND THEN THE 2ND CYPHER SELECT+ WAS REDELIVERED BUT THAT WAS UNSUCCESSFUL. THE CYPHER SELECT+ WAS RETRIEVED FROM THE PATIENT. THE PHYSICIAN CONFIRMED THE STENT TO BE FLARED AT THE PROXIMAL END OUTSIDE OF THE PATIENT SO HE STOPPED USING THE 2ND CYPHER SELECT+. BECAUSE THE PATIENT WAS AN ELDERLY PATIENT IN ORDER TO AVOID THE EXTENSION OF THE PROCEDURE AND THE USE OF TOO MUCH CONTRAST MEDIUM, THE PHYSICIAN STOPPED USING THE CYPHER SELECT+ AND THE PROCEDURE WAS FINISHED SUCCESSFULLY WITH POBA ONLY (I.E. PRE-DILATION). THERE WAS NO PATIENT INJURY REPORTED. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. THE TARGET LESION WAS THE PROXIMAL TO MID RIGHT CORONARY ARTERY (RCA) ((B)(4)). THE LESION WAS A DE NOVO, DIFFUSED, SLIGHTLY CALCIFIED AND HIGHLY TORTUOUS. THERE WAS 99% STENOSIS AT (B)(4) AND 75% AT (B)(4). PRIOR TO INSERTING THE SDS IN THE CATHETER THE BALLOON WAS NOT INFLATED OR PARTIALLY INFLATED. THERE WAS NO REPORT OF ANY RESISTANCE EXPERIENCED WHILE DELIVERING THE UNIT THROUGH THE GUIDING CATHETER. TRACKING DIFFICULTY WAS NOT EXPERIENCED. THE SYSTEM WAS SYSTEM REMOVED AND REINSERTED SEVERAL TIMES. THE PHYSICIAN DID NOT INDICATE OF ANY DIFFICULTY EXPERIENCED WHILE REMOVING THE DEVICE FROM THE PATIENT.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT PC REMAINS ON THE METER DISPLAY. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 3008080

    Patients

    Seq Age Sex Outcome Treatment
    1