BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 13206383 · Received January 10, 2022

    Report

    Report Number
    1820334-2022-00036
    Event Type
    Malfunction
    Date Received
    January 10, 2022
    Date of Event
    December 23, 2021
    Report Date
    April 26, 2022
    Manufacturer
    COOK INC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) NUMBER = PER THE REPORTER, THE COMPLAINT DEVICE MAY BE A 6 FRENCH, 45-CENTIMETER ANSEL SHEATH (ALTHOUGH NOT CONFIRMED). THE 510(K) FOR COOK 6 FRENCH ANSEL SHEATHS IS K142829. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED, DURING AN UNKNOWN PROCEDURE, AN UNSPECIFIED COOK FLEXOR ANSEL SHEATH UNRAVELED UPON REMOVAL OF THE DEVICE. INVESTIGATION EVALUATION: REVIEWS OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. IN RESPONSE TO THIS COMPLAINT, COOK COULD NOT COMPLETE A REVIEW OF THE DEVICE HISTORY RECORD (DHR) DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY. A GLOBAL SHIPMENT SEARCH FOR ALL DEVICES THE REPORTING CUSTOMER HAS BOUGHT IN THE PAST 3 YEARS WAS PERFORMED BUT COULD NOT DEFINITIVELY DETERMINE THE LOT NUMBER OF THE COMPLAINT DEVICE. AT THIS TIME, COOK COULD NOT CONCLUDE THAT NONCONFORMING PRODUCT FROM THE AFFECTED LOT EXISTS IN HOUSE OR IN THE FIELD. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR AND THE IFU, SUGGEST THAT THERE IS NO EVIDENCE THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: WARNINGS ¿IF RESISTANCE IS ENCOUNTERED DURING ADVANCEMENT OF FLEXOR SHEATH, ASSESS CAUSE OR RESISTANCE AND CONSIDER DILATION OF ANY RESTRICTION IDENTIFIED OR CONSIDERED ALTERNATE TREATMENT STRATEGY. IF FLEXOR SHEATH IS ADVANCED THROUGH RESISTANCE, FORCE TO REMOVE THE SHEATH WILL BE HIGHER, INCREASING THE RISK OF SHEATH MATERIAL OR HUB SEPARATION UPON WITHDRAWAL.¿ ¿REINSERTING OF DILATOR PRIOR TO REMOVAL OF FLEXOR SHEATH INCREASES THE STRENGTH OF THE SHEATH AND LESSENS THE RISK OF DEVICE SEPARATION. IF RESISTANCE IS ANTICIPATED OR ENCOUNTERED DURING WITHDRAWAL OF FLEXOR SHEATH, CONSIDER CAREFULLY REINSERTING THE DILATOR PRIOR TO CONTINUING REMOVAL.¿ SHEATH REMOVAL ¿INSERT A WIRE GUIDE UNTIL ITS TIP EXTENDS AT LEAST 10 CM PAST THE TIP OF THE SHEATH.¿ ¿REMOVE THE SHEATH. AVOID APPLYING TRACTION TO HUB DURING REMOVAL. IF RESISTANCE IS ANTICIPATED OR ENCOUNTERED DURING WITHDRAWAL OF THE FLEXOR SHEATH, CONSIDER REINSERTING THE DILATOR AND REMOVING THE SHEATH AND DILATOR AS A UNIT.¿ ¿REMOVE THE WIRE GUIDE.¿ COOK HAS CONCLUDED THAT FOR THIS FAILURE MODE A CAUSE COULD NOT BE ESTABLISHED DUE TO A CAPA (CORRECTIVE AND PREVENTATIVE ACTIONS) OPENED. THE CAPA ACTIVITIES ARE CURRENTLY ONGOING. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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

    AS REPORTED, DURING AN UNKNOWN PROCEDURE, AN UNSPECIFIED COOK FLEXOR ANSEL SHEATH UNRAVELED UPON REMOVAL OF THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356784 UNKNOWN DYB INTRODUCER, CATHETER DYB COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown