BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMCATH

    MDR report key: 12294372 · Received August 9, 2021

    Report

    Report Number
    3009211636-2021-00200
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Date of Event
    July 20, 2021
    Report Date
    November 9, 2021
    Manufacturer
    COVIDIEN MFG SOLUTIONS S.A.
    Product Code
    FIQ
    UDI-DI
    10884521009813
    PMA / PMN Number
    K840415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THE CANNULA WAS FOUND TO HAVE A LEAK. IT WAS REPORTED THAT THE CATHETER SHAFT DISCONNECTS FROM THE HUB/BIFURCATE. THE REPORTED ISSUE WAS CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THIS ISSUE MAY OCCUR WHEN CONTACT IS MADE WITH A SHARP SURGICAL INSTRUMENT DURING CLINICAL APPLICATION. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. A SECONDARY REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO POTENTIALLY CONTRIBUTING FACTORS. THE INSTRUCTIONS INCLUDED WITH THIS DEVICE PROVIDE THE FOLLOWING GUIDANCE: INSPECT THE CATHETER FREQUENTLY FOR NICKS, SCRAPES, CUTS, ETC. WHICH COULD IMPAIR PERFORMANCE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE CATHETER WAS ONLY IMPLANTED FOR A FEW WEEKS, WHILE THE CATHETER WAS BEING REMOVED, THE LUMEN AND UPPER PORTION BROKE OFF FROM THE BOTTOM HALF, LEAVING THE CUFF AND DISTAL PORTION OF THE CATHETER IN THE PATIENT. THEY HAD TO CUT DOWN FURTHER THAN USUAL TO EXTRACT THE BROKEN CATHETER PIECE AND DISLODGE THE CUFF AND THERE WAS NO FURTHER ISSUE. IT WAS STATED THAT THERE WAS NO ADDITIONAL INTERVENTION REQUIRED AND THAT ALL WAS DONE AS PART OF THE SAME REMOVAL PROCESS. THEY DID NOT REQUIRE ANY DIAGNOSTIC TESTING (X-RAYS OR FLUOROSCOPY). NO EXCESSIVE FORCE WAS USED IN TAKING OUT THE CATHETER, AND THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, AND THERE WAS NO LUER ADAPTER ISSUE. IT WAS STATED THAT THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY (STABLE WI TH NO ADDITIONAL ISSUES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193099 PERMCATH CANNULA, A-V SHUNT FIQ COVIDIEN MFG SOLUTIONS S.A. 8815132001 10884521009813

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male