BEUDAMED
    FDA Adverse Event Death Summary report: N

    PVC CATHETERS STRAIGHT

    MDR report key: 12406730 · Received September 1, 2021

    Report

    Report Number
    3011175548-2021-00907
    Event Type
    Death
    Date Received
    September 1, 2021
    Date of Event
    July 7, 2021
    Report Date
    May 23, 2022
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    GBZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE DETAILS OF THE COMPLAINT THE PHYSICIAN USED 2 SEPARATE 8FR PVC CATHETERS DURING THE PROCEDURE. THE DESCRIBED EVENT ALSO INDICATES THAT THE PHYSICIAN WAS UNHAPPY THAT THE ATRIUM DEVICE DID NOT HAVE A TROCAR AND THAT THE TIP WAS NOT PATENT AND THAT THE EYELETS WERE BEING BLOCKED BY TISSUE. THIS HAS BEEN CLAIMED TO CAUSE UNDUE STRESS ON THE PATIENT UNTIL A LARGER FRENCH SIZE DEVICE WAS USED TO HELP RESOLVE THE ISSUE WITH THE PATIENT WHO UNFORTUNATELY PASSED. THE PVC 8 FRENCH THORACIC CATHETERS USED IN THE CASE WERE NOT RETURNED FOR EVALUATION AND THE PRODUCT LOT NUMBER NOT PROVIDED. BASED ON THE DETAILS OF THE COMPLAINT IT IS CLEAR THAT THE ATRIUM CATHETERS WERE NOT IDEAL FOR THE PATIENT CONDITIONS. THE TIP OF THE CATHETER HOWEVER CLAIMED TO BE NOT PATENT IS ACTUALLY PATENT BY DESIGN BUT WITHOUT THE ACTUAL RETURNED DEVICES, THE ALLEGED CLAIM CANNOT BE CONFIRMED. THE PRODUCT SPECIFICATION SHOWS THERE IS A THROUGH HOLE AT THE TIP AS WELL AS THE TWO EYELETS AS IDENTIFIED WITHIN THE PRODUCT SPECIFICATION 356408 REVISION AJ. THE CURRENT REVISION OF THE PART SPECIFICATION DRAWING HAS NOT CHANGED SINCE APRIL 2018. IT IS IMPORTANT TO NOTE THAT IF TISSUE WAS BLOCKING THESE EYELETS, IT IS LIKELY THAT THE CATHETERS WERE NOT PLACED APPROPRIATELY. AS THERE WAS NO LOT NUMBER PROVIDED THE DEVICE HISTORY RECORDS ASSOCIATED WITH THESE CATHETERS COULD NOT BE REVIEWED. THE CATHETERS WHEN RECEIVED FROM THE VENDOR ARE VERIFIED TO ENSURE THE PRODUCT MET ALL INSPECTION CRITERIA PRIOR TO BEING RELEASED. THE PRODUCT IS RECEIVED FROM THE SUPPLIER PRE PACKAGED. A REVIEW OF THE SUPPLIER CORRECTIVE ACTION REQUESTS HAS SHOWN THAT THERE HAS BEEN NO SCARS FOR MISSING EYELETS OR THE INNER DIAMETER THROUGH HOLE. THE SCAR REVIEW IS ATTACHED TO THIS COMPLAINT. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN MORE INFORMATION REGARDING THIS CASE WERE MADE BUT NOT ANSWERED. THE QUESTIONS WERE THE FOLLOWING; ADDITIONAL INFORMATION REQUESTED FROM THE HOSPITAL: WHAT CHEST DRAIN WAS THE THORACIC CATHETER ATTACHED TO? WAS SUCTION BEING APPLIED? IF SO, AT WHAT LEVEL? WAS BUBBLING SEEN IN THE WATER SEAL CONFIRMING THE PROPER PLACEMENT OF THE CATHETER, PATENCY OF THE THORACIC CATHETER, AND PRESENCE OF A PNEUMOTHORAX? WAS THE INITIAL CHEST TUBE INSERTED AN ATRIUM 8FR PVC CATHETER? HOW WAS THE ¿40ML OF AIR¿ REMOVED? NEEDLE ASPIRATION VIA CHEST DRAIN OR NEEDLE INSERTION DIRECTLY INTO PLEURAL SPACE? HOW WAS THE RE-ACCUMULATION OF AIR DETECTED? VIA X-RAY OR VIA NO BUBBLING SEEN IN THE CHEST DRAIN WATER SEAL? WAS THE PNEUMOTHORAX ON DAY 2 A NEW PNEUMOTHORAX OR A RE-ACCUMULATION OF AIR FROM INITIAL PNEUMOTHORAX? HOW WAS THE ¿140ML OF AIR WAS REMOVED¿ FROM THE SYSTEM? HOW WAS THE ADDITIONAL 50ML ASPIRATED WITH A SYRINGE? VIA TUBING WITH NEEDLE OR VIA LUER LOCK CONNECTOR? WAS THE 2ND CHEST TUBE INSERTED ALSO AN ATRIUM 8FR PVC CATHETER? HOW WAS THE RE-ACCUMULATION OF AIR DETECTED? VIA X-RAY OR VIA NO BUBBLING SEEN IN THE CHEST DRAIN WATER SEAL? HOW WAS THE ADDITIONAL ¿185ML OF AIR¿ WAS REMOVED FROM THE SYSTEM? VIA SYRINGE AND TUBING OR VIA LUER LOCK CONNECTOR? WAS THE LACK OF TROCAR AN ISSUE DURING CATHETER PLACEMENT? WHAT BRAND/MODEL OF 9.6FR SILICONE CATHETER WAS USED FOR THE 3RD CATHETER INSERTION? WHAT WAS THE DIAGNOSIS OR CAUSE FOR THE NEED OF THE PLACEMENT OF THE CATHETERS? WHAT TYPE OF CATHETER WAS THE FIRST CATHETER THAT WAS PLACED AND HOW DID THE FIRST CATHETER FAIL? DID ALL CATHETERS LEFT IN PLACE WHEN THE NEW ONES WERE PLACED? 18. WHAT WAS THE CAUSE OF DEATH AND WHAT WERE THE CONTRIBUTING FACTORS? WITHOUT A RESPONSE TO THE MULTIPLE QUESTIONS ASKED MAKES A ROOT CAUSE DIFFICULT TO DETERMINE. BASED ON THE DETAILS OF THE COMPLAINT AND LACK OF A RESPONSE FROM THE COMPLAINANT THERE IS NO INDICATION THAT THE THORACIC CATHETERS USED IN THE CASE WERE FAULTY AND OR WERE THE CAUSE OF THE PATIENTS DEATH. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AND OR A USER PREFERENCE ISSUE AS THE CHEST TUBE IS NOT PROVIDED WITH A TROCAR. ALTHOUGH USE OF AN ATRIUM CHEST DRAIN INDICATED TO FACILITATE THE EVACUATION OF AIR AND/OR FLUID FROM THE CHEST CAVITY OR MEDIASTINUM, IT IS NOT SUPPLIED WITH CHEST DRAIN TROCAR FOR PLACEMENT. BASED ON THE DETAILS OF THE COMPLAINT THE EYELETS WERE POSSIBLY BEING BLOCKED BY THE PATIENT'S SOFT TISSUES. ADDITIONALLY THE TIP OF THE CATHETER IS PATENT BY DESIGN. THE PHYSICIAN CLAIMED THAT IT WAS NOT PATENT HOWEVER THIS CLAIM CANNOT BE SUBSTANTIATED WITHOUT THE ACTUAL DEVICE BEING RETURNED. THE PHYSICIAN ALSO WAS ABLE TO RESOLVE THE ISSUES HE OR SHE WAS HAVING BY UPSIZING TO A LARGER CATHETER AS INDICATED IN THE COMPLAINT DETAILS. THIS ALSO SUGGESTS THAT THE PROPERLY SIZED DEVICE WAS NOT CHOSEN INITIALLY. BASED ON THE INVESTIGATION RESULTS EVALUATING SAMPLES FROM INVENTORY IS NOT REQUIRED AS THERE IS NO EVIDENCE TO CONCLUDE THE DEVICE WAS FAULTY AND NO LOT NUMBER WAS PROVIDED. THE PRODUCT IS SUPPLIED PATENT AND WITH THE TWO EYELETS. THERE WAS ALSO NO ASSERTION THAT THE DEVICE WAS FAULTY WITHIN THE COMPLAINT DETAILS. THE DETAILS OF THE INVESTIGATION SUGGEST THE ATRIUM THORACIC CATHETER FINISHED GOOD CODE 8008 WAS NOT THE OPTIMUM PRODUCT FOR THE PATIENTS CONDITIONS. IN THIS REGARD THE COMPLAINT CANNOT BE CONFIRMED AND THERE IS NO INDICATION THE ATRIUM THORACIC CATHETER WAS FAULTY.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT HAD ONE OF THE PERCUTANEOUS CT'S IN PLACE. LATER ON HE SUFFERED A DECOMPENSATION WHICH TURNED OUT TO BE RE-ACCUMULATION OF A PNEUMOTHORAX. 40ML OF AIR WAS REMOVED WITH RAPID RE­ ACCUMULATION OF THE PNEUMOTHORAX. AN 8 FR ATRIUM CHEST TUBE (CT) WAS PLACED WHILE LEAVING THE PREVIOUS CT IN PLACE. THE ATRIUM CT IS PVC BASED AND CAME WITHOUT A TROCAR. THE ATRIUM CT WAS IN GOOD POSITION, ANTERIOR TO THE LUNG AND INITIALLY SEEMED TO WORK WELL. THE FOLLOWING DAY, THE PERCUTANEOUS CT SINCE THERE WAS NO ACTIVITY AND NO PNEUMOTHORAX ON CXR. THE NEXT DAY, THE PATIENT AGAIN SUFFERED ANOTHER SETBACK, WHICH WAS REVEALED TO BE ANOTHER PNEUMOTHORAX. THIS TIME 140ML OF AIR WAS REMOVED AND AN ADDITIONAL 50 ML WAS ASPIRATED WHEN A SYRINGE WAS ATTACHED TO IT. THIS IMPLIED THAT THE CT WAS NOT BLOCKED YET IT FAILED TO WORK. A 2ND ATRIUM CT WAS PLACED ABOVE THE PREVIOUS AND AGAIN, ALL SEEMED WELL FROM A PNEUMOTHORAX STANDPOINT. THE NEXT DAY, WITH 2 ATRIUM CT'S IN GOOD POSITION, THE PATIENT REACCUMULATED ANOTHER TENSION PNEUMOTHORAX, ONLY THIS TIME WE TAPPED 185ML OF AIR. THE ATRIUM CT'S WERE NOT PERFORMING WELL AND A 3RD WAS PLACED CT BELOW THE OTHER 2, THIS TIME USING A 9.6 SILICONE TUBE FROM ANOTHER COMPANY. AFTER THIS ONE WAS PLACED, THE PATIENT HAD NO MORE ISSUES WITH PNEUMOTHORAX RE-ACCUMULATION UP UNTIL THE TIME OF HIS DEMISE. THE 8FR ATRIUM CATHETER DOES NOT HAVE A TROCAR AND THE TIP IS NOT PATENT. IT HAS 2 SIDE PORTHOLES FOR DRAINAGE. THESE PORTHOLES JUST HAVE BECOME OBSTRUCTED WITH LUNG TISSUE ETC. AND HENCE FAILED TO DRAIN THE FREE AIR. THE OTHER PRODUCT DOES HAVE A TROCAR AND HAS A PATENT TIP AS WELL AS 2 PROXIMAL PORTHOLES. THE PHYSICIAN FELT THAT THE LACK OF AN OPENING AT THE TIP OF THE ATRIUM WAS THE CRITICAL ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308699 PVC CATHETERS STRAIGHT CATHETER, CHOLANGIOGRAPHY GBZ ATRIUM MEDICAL CORPORATION 8008 - CATHETER 8 FR STRAIGHT

    Patients

    Seq Age Sex Outcome Treatment
    1 23 WK Male Death