BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYETHYLENE ANGIOGRAPHIC CATHETER

    MDR report key: 14013316 · Received April 5, 2022

    Report

    Report Number
    1820334-2022-00529
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Date of Event
    March 9, 2022
    Report Date
    May 31, 2022
    Manufacturer
    COOK INC
    Product Code
    DQO
    UDI-DI
    00827002001749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) NUMBER = K180286. DEVICE EVALUATED BY MFG = DEVICE EVALUATION HAS BEGUN; HOWEVER, A CONCLUSION IS NOT YET AVAILABLE. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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.

    Additional Manufacturer Narrative · 0

    EVENT SUMMARY. AS REPORTED, TWO POLYETHYLENE ANGIOGRAPHIC CATHETERS SPLIT DURING A PULMONARY ANGIOGRAM INVOLVING THE RIGHT COMMON FEMORAL VEIN. THE DEVICES EACH SPLIT WHEN ADVANCING OVER A GUIDE WIRE. NEITHER DEVICE WAS ADVANCED FAR ENOUGH TO ENTER AN ANGIOGRAPHIC SHEATH ALREADY IN PLACE IN THE PATIENT. A NEW 100CM PIGTAIL CATHETER WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION ¿ EVALUATION. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT-BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. FOUR POLYETHYLENE ANGIOGRAPHIC CATHETERS WERE RECEIVED. TWO CATHETERS WERE IN A USED CONDITION AND THE OTHER TWO WERE IN UNUSED CONDITION STILL SEALED IN THE PACKAGE. THE TWO USED DEVICES WERE SPLIT ON THE APEX OF THE CURVE. VISUAL EXAMINATION OF THE UNUSED CATHETERS REVEALED THAT NEITHER OF THESE WERE DAMAGED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. BECAUSE THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER RELATED COMPLAINTS FROM THE LOT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: PRECAUTIONS:: ¿DUE TO THIN WALL CONSTRUCTION, EXTREME CARE MUST BE EXERCISED DURING MANIPULATION AND WITHDRAWAL.¿. INSTRUCTIONS FOR USE: ¿PEEL-AWAY STRAIGHTENER: ¿1. SLIDE PEEL-AWAY STRAIGHTENER FORWARD TO OPEN CATHETER TIP. 2. WITH CATHETER TIP STRAIGHT, ADVANCE CATHETER OVER WIRE GUIDE. 3. AFTER INITIAL ADVANCEMENT OF CATHETER OVER THE WIRE GUIDE, PULL BACK AND PEEL AWAY THE STRAIGHTENER FOR CATHETER INTRODUCTION.¿. COOK HAS CONCLUDED THAT A COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THIS INCIDENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. 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

    AS REPORTED, TWO POLYETHYLENE ANGIOGRAPHIC CATHETERS SPLIT DURING A PULMONARY ANGIOGRAM INVOLVING THE RIGHT COMMON FEMORAL VEIN. THE DEVICES EACH SPLIT WHEN ADVANCING OVER A GUIDE WIRE. NEITHER DEVICE WAS ADVANCED FAR ENOUGH TO ENTER AN ANGIOGRAPHIC SHEATH ALREADY IN PLACE IN THE PATIENT. A NEW 100CM PIGTAIL CATHETER WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    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
    83940 POLYETHYLENE ANGIOGRAPHIC CATHETER DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK INC G00174 9751006 00827002001749

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown