BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    MDR report key: 5090641 · Received September 21, 2015

    Report

    Report Number
    1820334-2015-00595
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    August 7, 2015
    Report Date
    August 24, 2015
    Manufacturer
    COOK INC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: A REVIEW OF THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL (QC), TRENDS AND A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS CONDUCTED FOR THE PURPOSE OF THIS INVESTIGATION. THE CUSTOMER RETURNED ONE OUTER CATHETER FROM THE MPIS SET. THE CATHETER SHAFT WAS STRETCHED AND SEPARATED FROM THE HUB. UPON EXAMINATION, THE HUB HAD SHAFT MATERIAL CONTAINED IN THE HUB. THE SHAFT STRETCHED AND SEPARATED AT THE HUB, BUT BASED ON THE STRETCHING OF THE SHAFT AND THE SHAFT MATERIAL STILL IN THE HUB, THE DETACHMENT NOTED BY THE CUSTOMER IS DETERMINED TO BE SHAFT SEPARATION. THE SHAFT MEASURED 10.6CM WITHOUT THE HUB INDICATING THAT THE SHAFT WAS STRETCHED. ALSO THE SHAFT WAS BENT AT 4 CM DISTAL TO THE SEPARATION AND THE BEND WAS ABOUT 5 DEGREES. A SEARCH OF COMPLAINTS REVEALED THIS TO BE THE ONLY REPORTED COMPLAINT REPORTED AGAINST LOT 5970379. PER QC, INSPECTION IS CONDUCTED TO CONFIRM THAT THE SURFACE IS CLEAN AND FREE OF IMPERFECTIONS AND THE DIMENSIONS OF THE INNER AND OUTER DIMENSIONS. IN FINAL INSPECTION, QC PERSONNEL CONFIRMS THE TYPE AND OUTSIDE DIAMETER OF TUBING FOR THE CATHETER AND THAT THE SURFACE OF THE CATHETER IS SMOOTH AND CLEAN, FREE OF EXCESSIVE DENTS AND KINKS. THE DEVICE IS SHIPPED WITH IFU WHICH INCLUDES INFORMATION ON INTENDED USE, PRECAUTIONS, WARNINGS, POTENTIAL ADVERSE EVENTS, AND INSTRUCTIONS FOR PROPER USE OF THE DEVICE. WE ARE UNABLE TO DETERMINE A ROOT CAUSE OF THIS EVENT, THOUGH IT IS POSSIBLE TO SUGGEST THAT THE NOTED SCARRING MAY HAVE CONTRIBUTED TO INCREASED FORCE REQUIRED TO PLACE AND REMOVE THE DEVICE LEADING TO THE NOTED SEPARATION. WE HAVE NOTIFIED APPROPRIATE INTERNAL PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A FEMORAL ARTERY PUNCTURE FOR ANGIOPLASTY PROCEDURE WAS BEING PERFORMED (FEMORAL PUNCTURE ON SCARRED GROIN). UPON REMOVAL OF THE INTRODUCER CATHETER MICROPUNCTURE SET, THE HUB BECAME DETACHED. THE REMAINING CATHETER PORTION WAS POSITIONED WITH THE PROXIMAL END JUST OUTSIDE THE SKIN SURFACE AND WAS THEREFORE ABLE TO BE RETRIEVED WITHOUT REQUIRING FURTHER INTERVENTION A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    A FEMORAL ARTERY PUNCTURE FOR ANGIOPLASTY PROCEDURE WAS BEING PERFORMED (FEMORAL PUNCTURE ON SCARRED GROIN). UPON REMOVAL OF THE INTRODUCER CATHETER MICROPUNCTURE SET, THE HUB BECAME DETACHED. THE REMAINING CATHETER PORTION WAS POSITIONED WITH THE PROXIMAL END JUST OUTSIDE THE SKIN SURFACE AND WAS THEREFORE ABLE TO BE RETRIEVED WITHOUT REQUIRING FURTHER INTERVENTION A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622555 MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1