BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PRODUCT - CORDIS CORPORATION

    MDR report key: 15191203 · Received August 9, 2022

    Report

    Report Number
    9616099-2022-05894
    Event Type
    Injury
    Date Received
    August 9, 2022
    Date of Event
    January 1, 1980
    Report Date
    August 9, 2022
    Manufacturer
    CORDIS CORPORATION
    Product Code
    LIT
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXACT CORDIS DEVICE IS UNKNOWN, THEREFORE PRODUCT CODE OF LIT WAS CHOSEN DUE TO BURST. BASES ON INFORMATION PROVIDED. AS REPORTED, CALLER STATED THEY HAD AN UNKNOWN CORDIS DEVICE IMPLANTED IN HIM/HER THAT EXPLODED, BECAUSE OF THIS THE CALLER HAD TO POSTPONE ANOTHER SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS EVENT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO LOT NUMBER WAS PROVIDED THEREFORE A PRODUCT HISTORY RECORD (PHR) REVIEW COULD NOT BE GENERATED. THE REPORTED ¿BALLOON-SDS BURST¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE CANNOT BE DETERMINED. WITH THE LIMITED AMOUNT OF INFORMATION PROVIDED IT IS DIFFICULT TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT REPORTED. IT IS UNCLEAR IF AS TO WHAT CORDIS DEVICE WAS INVOLVED IN THE EVENT. VESSEL CHARACTERISTICS, ALTHOUGH UNKNOWN, OR PROCEDURAL OR HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. ACCORDING TO THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE ¿PRIOR TO STENTING, THE PALMAZ GENESIS PERIPHERAL STENT ON OPTA PRO .035" DELIVERY SYSTEM SHOULD BE EXAMINED TO VERIFY FUNCTIONALITY AND INTEGRITY. TO ASSURE FULL EXPANSION, INFLATE TO AT LEAST THE RECOMMENDED NOMINAL PRESSURE AS SHOWN ON THE LABEL. DO NOT EXCEED THE RATED BURST PRESSURE RECOMMENDED ON THE LABEL. THE RATED BURST PRESSURE IS BASED ON THE RESULTS OF IN-VITRO TESTING. AT LEAST 99.9% OF THE BALLOONS (WITH A 95% CONFIDENCE), WILL NOT BURST AT OR BELOW THEIR RATED BURST PRESSURE. USE OF A PRESSURE MONITORING DEVICE IS RECOMMENDED TO PREVENT OVER PRESSURIZATION. WHEN CATHETERS ARE IN THE BODY, THEY SHOULD BE MANIPULATED ONLY UNDER FLUOROSCOPY. DO NOT ADVANCE OR RETRACT THE CATHETER UNLESS THE BALLOON IS FULLY DEFLATED UNDER VACUUM. RECROSSING A PARTIALLY OR FULLY DEPLOYED STENT WITH ADJUNCT DEVICES MUST BE PERFORMED WITH EXTREME CAUTION. DO NOT ATTEMPT TO REMOVE OR READJUST THE STENT ON THE DELIVERY SYSTEM. CAUTION: IF STRONG RESISTANCE IS MET DURING ADVANCEMENT OR WITHDRAWAL OF THE CATHETER, DISCONTINUE MOVEMENT AND DETERMINE THE CAUSE OF RESISTANCE BEFORE PROCEEDING. IF THE CAUSE OF RESISTANCE CANNOT BE DETERMINED, WITHDRAW THE ENTIRE SYSTEM. UNDER FLUOROSCOPY, USE THE BALLOON MARKER BANDS AND THE RADIOPAQUE STENT TO POSITION THE STENT CENTRALLY WITHIN THE LESION. DURING POSITIONING, VERIFY THAT THE STENT IS STILL CENTERED WITHIN THE BALLOON MARKER BANDS AND HAS NOT BEEN DISLODGED.¿ WITHOUT A LOT NUMBER TO CONDUCT A PHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED, CALLER STATED THEY HAD AN UNKNOWN CORDIS DEVICE IMPLANTED IN HIM/HER THAT EXPLODED, BECAUSE OF THIS THE CALLER HAD TO POSTPONE ANOTHER SURGERY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1988156 UNK - PRODUCT - CORDIS CORPORATION CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT CORDIS CORPORATION UNK - PRODUCT - CORDIS CORPORATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| O