BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYB INTRODUCER, CATHETER

    MDR report key: 8595580 · Received May 9, 2019

    Report

    Report Number
    1820334-2019-01187
    Event Type
    Injury
    Date Received
    May 9, 2019
    Report Date
    June 27, 2019
    Manufacturer
    COOK INC
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION - EVALUATION. REVIEWS OF THE DRAWINGS, INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S INSTRUCTIONS, AND QUALITY CONTROL 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. ADDITIONALLY, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, DRAWINGS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. FURTHERMORE, THOUGH THE JOURNAL ARTICLE DOES NOT PROVIDE AN RPN FOR THE DEVICE, THE IFU WAS REVIEWED FOR THE RPN¿S THAT HAVE AN IFU ON THE OUTER PACKAGING. THAT IFU PROVIDES THE FOLLOWING ¿PRECAUTIONS -WHEN INSERTING, MANIPULATING OR WITHDRAWING A DEVICE THROUGH AN INTRODUCER, ALWAYS MAINTAIN INTRODUCER POSITION. DO NOT ATTEMPT TO INSERT OR WITHDRAW THE WIRE GUIDE AND/OR INTRODUCER IF RESISTANCE IS FELT. HOW SUPPLIED - UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ BASED ON THE INFORMATION PROVIDED AND NO PRODUCT RETURNED, INVESTIGATION HAS CONCLUDED THAT THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATIONS. ACCORDINGLY, THIS EVENT CANNOT BE TRACED TO THE DEVICE, BUT LIKELY TO THE PROCEDURE. REPORTEDLY, THE DEVICE WAS ADVANCED THROUGH A PREVIOUSLY-PLACED VASCULAR CLOSURE CLIP DURING THE PROCEDURE. THIS WOULD EXPLAIN THE DIFFICULT IN ADVANCING THE OTHER MANUFACTURER¿S DEVICE AS WELL AS THE SEPARATION OF THE COOK COMPLAINT 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

    COMMON NAME = UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: STARCLOSE SYSTEM (ABBOTT), 5-F SHEATH (NAVILYST MEDICAL) 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 SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE, DURING A DIAGNOSTIC CEREBRAL ANGIOGRAPHY, A COOK MICROPUNCTURE PUSH PLUS DILATOR SEPARATED. THE (B)(6) MALE PATIENT REPORTEDLY HAD A HISTORY OF SEVERAL CEREBRAL AND CORONARY ANGIOGRAMS. AN UNKNOWN 21 GAUGE NEEDLE WAS USED TO OBTAIN ACCESS. ATTEMPTS TO PASS ANOTHER MANUFACTURER'S 5 FRENCH SHEATH WERE UNSUCCESSFUL, THOUGHT TO BE DUE TO A DENSE FIBROUS SCAR. THE 4 FRENCH COOK MICROPUNCTURE DILATOR WAS ADVANCED OVER THE WIRE INTO THE COMMON FEMORAL ARTERY. THE INNER DILATOR AND 0.018- INCH WIRE WERE REMOVED, AND A 0.035-INCH COOK BENTSON WIRE WAS ADVANCED INTO THE ABDOMINAL AORTA. DURING REMOVAL, THE 4 FR DILATOR FRACTURED AT ITS MIDPOINT WITH THE RETAINED PORTION OF THE DILATOR OVER THE WIRE INSIDE THE RIGHT COMMON FEMORAL ARTERY. UNSUCCESSFUL ATTEMPTS WERE MADE TO REMOVE THE RETAINED DILATOR FRAGMENT BY PASSING ANOTHER MANUFACTURER'S 5 FR INTRODUCER SHEATH OVER THE 0.035-INCH WIRE INTO THE RIGHT COMMON FEMORAL ARTERY. AFTER OBTAINING THROUGH-AND-THROUGH WIRE ACCESS, ANOTHER MANUFACTURER'S 45 CENTIMETER 6 FR WAS PLACED VIA THE CONTRALATERAL COMMON FEMORAL ARTERY. THE STRATEGY INVOLVED PUSHING THE RETAINED PORTION OF THE DILATOR OUT OF THE RIGHT FEMORAL ARTERIOTOMY. DESPITE REPEATED ATTEMPTS, THE RETAINED DILATOR COMPRESSED OVER THE WIRE IN AN ACCORDION FASHION, REMAINED FIXED, AND DID NOT PROGRESS OUT OF THE RIGHT FEMORAL ARTERIOTOMY. FURTHER ATTEMPTS AT ENDOVASCULAR REMOVAL, SUCH AS COAXIALLY SNARING THE FRAGMENT OVER THE WIRE, WERE CONSIDERED BUT ABANDONED BECAUSE OF A DESIRE TO AVOID APPLYING EXCESSIVE FORCE TO THE VESSEL. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM WITH SHEATHS AND WIRE IN PLACE. A RIGHT FEMORAL ARTERY CUTDOWN REVEALED THAT THE RIGHT ARTERIOTOMY WAS DIRECTLY THROUGH THE CENTER OF THE ANOTHER MANUFACTURER'S VASCULAR CLOSURE CLIP. THE COMPRESSED PIECE OF THE BROKEN 4-F DILATOR WAS REMOVED SUCCESSFULLY. BOTH FEMORAL ARTERY ACCESS SITES WERE CLOSED, AND THE PATIENT WAS DISCHARGED THE NEXT DAY. HE UNDERWENT ANGIOGRAPHY AT A LATER DATE. SIEBERT, D.R., MISSELT, A., HUNTER, D.,CRESSMAN, E. (2013). "TWO CASES OF FEMORAL ARTERIAL ACCESS THROUGH A PREVIOUSLY PLACED STARCLOSE CLIP." HTTP://DX.DOI.ORG/10.1016/J.JVIR.2013.04.032.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390536 DYB INTRODUCER, CATHETER DYB COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention