BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DQX WIRE, GUIDE, CATHETER

    MDR report key: 8636376 · Received May 23, 2019

    Report

    Report Number
    1820334-2019-01208
    Event Type
    Injury
    Date Received
    May 23, 2019
    Date of Event
    April 8, 2016
    Report Date
    July 8, 2019
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, MANUFACTURER¿S INSTRUCTIONS, QUALITY CONTROL, AND SPECIFICATIONS WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. FURTHERMORE, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, DRAWING, SPECIFICATIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. THROUGH THESE REVIEWS, COOK HAS DETERMINED THAT APPROPRIATE MEASURES ARE IN PLACE TO ADDRESS THIS FAILURE MODE PRIOR TO DISTRIBUTION. BASED ON THE INFORMATION PROVIDED AND NO PRODUCT RETURNED, INVESTIGATION HAS CONCLUDED THAT THIS EVENT CAN BE TRACED TO THE USER AND INTENTIONAL UNAPPROVED USE. REPORTEDLY, THE WIRE WAS USED IN A ROPE-LIKE FASHION IN ATTEMPTS TO RETRIEVE A SECONDARY DEVICE. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    DEVICE NAME = UNKNOWN AS RPN WAS NOT PROVIDED. PRODUCT CODE = DQX. LOT NUMBER = NOT PROVIDED. PMA/510(K) NUMBER = UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED AT THE CONCLUSION OF THE INVESTIGATION OR, WHEN ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    UPON MEDICAL RECORD REVIEW OF A RELATED EVENT (PLEASE REFERENCE MEDWATCH 3002808486-2017-00441), IT WAS LEARNED A "035 AMPLATZ WIRE" BROKE DURING DIFFICULT REMOVAL OF AN INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2016. AS REPORTED, MULTIPLE ATTEMPTS WERE MADE TO SNARE THE INFRARENAL FILTER, BUT THE HOOK WAS EMBEDDED IN THE WALL. THE RIGHT IJ SHEATH WAS UPSIZED TO A 14 FRENCH SIZE. A 5 FRENCH SOS CATHETER WAS ADVANCED THROUGH THE SHEATH AND USED TO FOCUS AT THE BASE OF THE FILTER. NEXT, AN 035 AMPLATZ WIRE WAS ADVANCED THROUGH THE REVERSE-CURVE CATHETER AND POINTED IN A CEPHALAD DIRECTION. A 2 CM GOOSE NECK SNARE DEVICE WAS SEPARATELY ADVANCED THROUGH THE 14 FRENCH SHEATH AND USED TO SNARE THE WIRE. TRACTION WAS HELD ON THE HOOKED IVC FILTER BY BOTH THE 5 FRENCH SOS CATHETER AND THE SNARED WIRE. MULTIPLE ATTEMPTS WERE MADE TO FREE THE FILTER FROM THE IVC WALL. THESE WERE UNSUCCESSFUL. DURING THE LAST ATTEMPT, THE WIRE BROKE AND A PIECE OF IT CURLED AROUND THE IVC FILTER WITH THE TIP OF THE SOS CATHETER. NUMEROUS ATTEMPTS WERE MADE TO SNARE THE WIRE AND A PIECE OF THE SOS CATHETER AND REMOVE IT. THESE WERE ULTIMATELY UNSUCCESSFUL. AT THIS POINT, THE PATIENT WAS ANXIOUS AND WANTED TO LEAVE THE ANGIOGRAPHY SUITE. DISCUSSIONS WERE HELD WITH THE PATIENT WHO WAS FULLY PRESENT ON THE SITUATION AND HE AGREED TO RETURN THE FOLLOWING DAY FOR ATTEMPTED RETRIEVAL. AN 11 FRENCH VASCULAR SHEATH WAS LEFT IN THE RIGHT INTERNAL JUGULAR VEIN WAS ACCESSED FOR THE NEXT DAY PROCEDURE. THE SHEATH WAS SUTURED TO THE SKIN AND OVERLYING STERILE BANDAGES WERE PLACED. THE PATIENT HAD A MODERATE SIZED HEMATOMA SURROUNDING THE ACCESS SITE. THE PATIENT TOLERATED THE PROCEDURE WELL. THERE WERE NO FURTHER PERIPROCEDURAL COMPLICATIONS. THE PATIENT WAS DISCHARGED TO THE INTENSIVE CARE UNIT FOR FURTHER MONITORING. ON (B)(6) 2016, THE PIECE OF THE COMPLAINT WIRE AND PREVIOUSLY IMBEDDED IVC FILTER WERE SUCCESSFULLY REMOVED IN THEIR ENTIRETY VIA ACCESS OF THE RIGHT INTERNAL JUGULAR VEIN AND RIGHT COMMON FEMORAL VEIN. COMPLETION VENOGRAM SHOWED NO EVIDENCE OF THROMBOSIS. THERE WERE NO PERIPROCEDURAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431172 DQX WIRE, GUIDE, CATHETER DQX

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other| R PREVIOUSLY STATED| PREVIOUSLY STATED