FDA Adverse Event No answer provided Summary report: N

COOK SPECTRUM

MDR report key: 15958417 · Received December 12, 2022

Report

Report Number
15958417
Event Type
No answer provided
Date Received
December 12, 2022
Date of Event
November 12, 2022
Report Date
December 7, 2022
Manufacturer
COOK INCORPORATED
Product Code
FOZ
Report Source
User Facility report
Reporter Location
CA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

SITUATION: PATIENT RETURNED FROM THE OR WITH A CORDIS IN THE RIGHT INTERNAL JUGULAR VEIN. THE PATIENT REQUIRED MORE CENTRAL ACCESS AND THE CORDIS WAS REWIRED TO A TRIPLE LUMEN CENTRAL CATHETER. AN X-RAY WAS PERFORMED AFTER THE LINE REWIRING WHICH REVEALED A RETAINED GUIDEWIRE. THE PRIMARY TEAM WAS NOT AWARE OF RETAINED GUIDEWIRE UNTIL REVIEWING FILMS THE NEXT MORNING. LATER THAT MORNING THE PATIENT WENT TO INTERVENTIONAL RADIOLOGY UNDER GENERAL ANESTHESIA FOR SUCCESSFUL WIRE RETRIEVAL. FOLLOW-UP CHEST X-RAY WAS PERFORMED THAT DEMONSTRATED THE GUIDEWIRE WAS IN PLACE, ALTHOUGH THIS CRITICAL RESULT WAS NOT COMMUNICATED TO THE PRIMARY TEAM. PER THE PROCEDURE NOTE BY DOCTOR, "PLACEMENT VERIFIED BY X-RAY AND NO PNEUMOTHORAX ON X-RAY." NEXT MORNING, UPON REVIEW OF IMAGING BY THE PRIMARY TEAM, IT WAS NOTED THAT THE GUIDEWIRE WAS STILL IN PLACE. IR WAS CONTACTED AND URGENTLY BROUGHT THE PATIENT DOWN FOR LINE REMOVAL. BACKGROUND: DAY 1 POST MULTIVISCERAL TRANSPLANT. NEW RIGHT IJ LINE PLACED. GUIDEWIRE WAS LEFT ENTIRELY WITHIN CATHETER, APPARENTLY UNNOTICED, AND NOT RECOGNIZED FOR APPROXIMATELY 24HRS, WHEN IT HAD TO BE RETRIEVED AND REMOVED BY IR. PROVIDER FOLLOW-UP: A PORTABLE CXR (CHEST X-RAY) WAS OBTAINED FOR CATHETER PLACEMENT. THE RADIOGRAPH WAS INTERPRETED AS BEING OBTAINED " DURING PLACEMENT OF A CENTRAL CATHETER VIA THE RIGHT INTERNAL JUGULAR VEIN AND DEMONSTRATES A GUIDEWIRE THAT PASSES THROUGH THE CATHETER AND INTO THE IVC BELOW THE FIELD OF VIEW." NOTE: IT IS COMMON FOR A CATHETER PLACEMENT CXR TO BE OBTAINED WITH THE GUIDEWIRE STILL IN PLACE TO CHECK THE POSITION OF THE CATHETER WITH THE INTENTION OF LATER REMOVING THE GUIDEWIRE. THE RADIOLOGIST WOULD NOTE THE GUIDEWIRE BUT WOULD NOT CONSIDER ITS PRESENCE A REASON TO CALL. EVEN THE LONG LENGTH OF GUIDEWIRE WOULD NOT BE A CAUSE FOR ALARM AS IT IS THE PRACTICE OF SOME PHYSICIANS TO EXTEND THE GUIDEWIRE THROUGH THE HEART INTO THE IVC TO BE SURE OF PLACEMENT IN THE CORRECT VESSEL. NOTE THAT AN US (ULTRASOUND) STUDY WAS OBTAINED THE REPORT STATES " THERE IS A LINEAR TRACT OF TISSUE WHICH WAS INITIALLY SUSPECTED TO REPRESENT THROMBUS IN THE IVC, HOWEVER AFTER DISCUSSION WITH THE TRANSPLANT FELLOW IT IS LIKELY THAT THIS APPEARANCE IS DUE TO A PIGGYBACK TRANSPLANT WITH DONOR AND NATIVE CAVA SUPERIMPOSED ON EACH OTHER". THIS ABNORMAL APPEARANCE WHICH WAS ACTUALLY THE GUIDEWIRE IN THE IVC LED TO A PHONE CALL BY THE RADIOLOGIST BUT WAS EXPLAINED AWAY BY THE CLINICIAN. A PORTABLE CXR WAS OBTAINED. THE REPORT READS : " AGAIN THERE IS AN ADDITIONAL CATHETER IN THE RIGHT NECK TERMINATING IN THE REGION OF THE CAVOATRIAL JUNCTION WITH A GUIDEWIRE THAT EXTENDS INFERIORLY INTO THE REGION OF THE IVC AND OFF IMAGE. PER DISCUSSION WITH THE PATIENT'S NURSE, THE CLINICAL TEAM IS AWARE. " THERE WAS MODERATE TEMPORARY HARM IN THIS EVENT WITH THE PATIENT RETURNING TO IR FOR REMOVAL UNDER GENERAL ANESTHESIA. ONLY THE GUIDEWIRE IN THE SPECTRUM CENTRAL VENOUS TRAY KIT IS THE PRODUCT BEING REPORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
424974 COOK SPECTRUM CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ COOK INCORPORATED G44126 14501754

Patients

Seq Age Sex Outcome Treatment
1 6935 DA Unknown