FDA Adverse Event Injury Summary report: N

ANGIODYNAMICS

MDR report key: 18172482 · Received November 17, 2023

Report

Report Number
MW5148289
Event Type
Injury
Date Received
November 17, 2023
Date of Event
November 14, 2023
Report Date
November 16, 2023
Manufacturer
NAVILYST MEDICAL, INC. / ANGIODYNAMICS
Product Code
DRE
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MI, US
Reporter Occupation
RISK MANAGER
Health Professional
Yes

Narratives

Description of Event or Problem · 0

IR INSERT TUNNELED CENTRAL VENOUS CATHETER WO PORT OR PUMP MORE 5YRS RIGHT PLANNED PROCEDURE: ULTRASOUND-GUIDED PERCUTANEOUS ACCESS OF RIGHT JUGULAR VEIN AND ATTEMPTED FLUOROSCOPICALLY GUIDED RETRIEVAL OF RETAINED FOREIGN BODY. COMPLETED DATE: 11/14/2023 1:38 PM CLINICAL HISTORY/PRE-PROCEDURE DIAGNOSIS: 34-YEAR-OLD FEMALE WITH END STAGE RENAL DISEASE ON HEMODIALYSIS. SHE WAS ADMITTED FOR CONCERN OF MALFUNCTIONING LEFT ARTERIOVENOUS FISTULA. LEFT AV FISTULA REQUIRES SURGICAL INTERVENTION AND DECISION MADE FOR PERMCATH PLACEMENT UNTIL THAT DATE. POST-PROCEDURE DIAGNOSIS: SAME ACCESS SITE: RIGHT INTERNAL JUGULAR VEIN PROCEDURE: AFTER DISCUSSION OF THE RISKS, BENEFITS AND ALTERNATIVES, AS WELL AS ANSWERING THE PATIENT'S QUESTIONS, INFORMED CONSENT WAS OBTAINED. DURING THE CONSENT PROCESS, SOLE MEDICAL USE OF THE CENTRAL VENOUS ACCESS CATHETER WAS DISCUSSED, AND THE PATIENT WAS INSTRUCTED AND AGREED NOT TO USE THE DEVICE FOR ANY OTHER PURPOSE. THE PATIENT'S HISTORY OF CENTRAL VENOUS ACCESS WAS REVIEWED AND NONDEDICATED IMAGING IF AVAILABLE, WAS REVIEWED. AFTER EMPLOYING ALL ELEMENTS OF MAXIMAL STERILE BARRIER TECHNIQUE INCLUDING CAP, MASK, STERILE GOWN, STERILE GLOVES, LARGE STERILE SHEET, HAND HYGIENE, 2% CHLORHEXIDINE FOR CUTANEOUS ANTISEPSIS, LOCAL ANESTHETIC AND STERILE ULTRASOUND PREPARATION WITH STERILE GEL AND PROBE COVER. THE RIGHT INTERNAL JUGULAR VEIN WAS EVALUATED WITH ULTRASOUND AND SEEN TO BE A PATENT VESSEL AND DOCUMENTED IN THE MEDICAL RECORD. THIS VESSEL WAS ENTERED VIA MICRO PUNCTURE KIT WITH 0.018 WIRE PASSED WITHOUT DIFFICULTY VIA SELDINGER TECHNIQUE UNDER CONTINUOUS ULTRASOUND GUIDANCE. THE 3-4FR DILATOR WAS THEN PLACED WITHOUT COMPLICATION. THE 0.018 WAS REMOVED AND BLEEDING NOTED AROUND HUB OF 3-4 DILATOR. ATTEMPT MADE TO ADVANCE 0.035 WIRE WITHOUT SUCCESS. AT THIS TIME DR. (B)(6) WAS CALLED TO THE ROOM. A 0.035 WIRE WAS ABLE TO BE ADVANCED THROUGH THE 4 FRENCH DILATOR INTO THE INFERIOR VENA CAVA; HOWEVER, WHEN ATTEMPTING TO WITHDRAW THE 4 FRENCH DILATOR, IT FRACTURED AT THE HUB. MULTIPLE ATTEMPTS WERE MADE TO VISUALIZE THE BROKEN FRAGMENT ALONG THE WIRE LENGTH UNDER FLUOROSCOPY ALTHOUGH THIS WAS UNSUCCESSFUL. THE FRACTURED FRAGMENT WAS ESTIMATED TO BE 3-4 CM IN LENGTH. A 7FR SHEATH WAS ADVANCED ALONG THE WIRE. A SNARE WAS THEN ADVANCED OVER THE WIRE IN AN ATTEMPT TO SNARE THE CATHETER FRAGMENT ALTHOUGH UNABLE TO VISUALIZE THE CATHETER FRAGMENT UNDER FLUOROSCOPY. ADDITIONAL ATTEMPTS WERE ABORTED, AND THE WIRE AND SHEATH WERE REMOVED. MULTIPLE FLUOROSCOPIC IMAGES WERE OBTAINED IN VARIOUS OBLIQUITIES AND A FAINT LINEAR PROJECTION WAS SEEN PROJECTING OVER RIGHT HEART AND MEDIAL RIGHT LOWER LOBE ON A FRONTAL PROJECTION, ALTHOUGH IT WAS DIFFICULT TO DETERMINE WHETHER THIS CATHETER FRAGMENT WAS IN THE RIGHT LOWER LOBE PULMONARY ARTERY OR IN THE RIGHT ATRIUM. ADDITIONAL IMAGES WERE OBTAINED, AND THE FAINT PROJECTION OF THE CATHETER COULD NO LONGER BE SEEN. THE DECISION WAS MADE TO ABORT ANY FURTHER ATTEMPTS OF CATHETER RETRIEVAL OR CATHETER PLACEMENT AND OBTAIN COMPUTED TOMOGRAPHY OF THE CHEST, PLEASE REFER TO THAT REPORT. A STERILE OCCLUSIVE DRESSING WAS APPLIED TO THE RIGHT VENOTOMY SITE. THE PATIENT WAS TAKEN TO CT FOR STAT CT OF THE CHEST IN STABLE CONDITION. THE PRIMARY TEAM WAS UPDATED ON ALL EVENTS OF THE PROCEDURE. IMPRESSION: UNSUCCESSFUL PLACEMENT OF A RIGHT IJ VEIN PERMCATH, WITH NEW RETAINED FOREIGN BODY OF 4 FRENCH TRANSITIONAL DILATOR FROM MICRO PUNCTURE ACCESS. IR TRANSCATH RETRIEVAL FOREIGN BODY PROCEDURE PERFORMED: FLUOROSCOPIC GUIDED INTRACARDIAC FOREIGN BODY REMOVAL  COMPLETED DATE: (B)(6) 2023 11:58 AM  CLINICAL HISTORY/PRE-PROCEDURE DIAGNOSIS: 34-YEAR-OLD FEMALE WITH RETAINED FOREIGN BODY IN THE RIGHT ATRIUM. THE EXAMINATION WAS PERFORMED UTILIZING ULTRASOUND AND FLUOROSCOPIC GUIDANCE WITH IMAGES STORED TO THE PACS. THE ECHOCARDIOGRAPHER WAS ALSO PRESENT WITHIN THE ANGIOGRAPHY SUITE TO PROVIDE ASSISTANCE WITH IMAGE GUIDANCE AND REMOVAL OF THE INTRACARDIAC FOREIGN BODY. ECHOCARDIOGRAPHY PERFORMED BY THE TECHNOLOGIST DEMONSTRATED A LINEAR ECHOGENIC FOREIGN BODY WITHIN THE RIGHT ATRIUM. UNDER ULTRASOUND GUIDANCE, A PATENT RIGHT COMMON FEMORAL VEIN WAS ACCESSED WITH A 4 FRENCH MICROPUNCTURE KIT FOLLOWED BY PLACEMENT OF A 7 FRENCH BY 55 CM SHEATH WHICH IS ADVANCED OVER THE WIRE INTO THE RIGHT ATRIUM. A CURVE WAS PLACED UPON THE SHEATH TO ALLOW DIRECTIONAL MANIPULATION. THROUGH THE SHEATH, AN ENSNARE CATHETER WAS ADVANCED INTO THE RIGHT ATRIUM AND INITIALLY MULTIPLE ATTEMPTS WERE MADE UTILIZING ECHOCARDIOGRAPHY TO SNARE THE FOREIGN BODY ALTHOUGH THIS WAS DIFFICULT AS WITH DIFFICULT TO DETERMINE THE LOCATION OF THE STENT DEVICE RELATIVE CATHETER. UNDER FLUOROSCOPY WAS ABLE TO SEE A FAINT SHADOW OF THE CATHETER MIGRATING BACK AND FORTH WITHIN THE RIGHT ATRIUM. EVENTUALLY I WAS ABLE TO SNARE THIS CATHETER UTILIZING THE SNARE DEVICE. THE RETAINED FOREIGN BODY WAS SUCCESSFULLY REMOVED THROUGH THE SHEATH. ECHOCARDIOGRAPHER OBTAIN ADDITIONAL IMAGES OF THE RIGHT ATRIUM CONFIRMING REMOVAL OF THE FOREIGN BODY. IMAGES OF THE FOREIGN BODY REMOVED FROM THE RIGHT ATRIUM WERE OBTAINED AND UPLOADED TO THE PATIENT'S CHART OF THE MEDIAL SECTION. REFERENCE REPORT: MW5148290.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2068317 ANGIODYNAMICS DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE NAVILYST MEDICAL, INC. / ANGIODYNAMICS 5798838

Patients

Seq Age Sex Outcome Treatment
1 34 YR Female Required Intervention| H