FDA Adverse Event Malfunction Summary report: N

SHERLOCK 3CG TIP LOCATION

MDR report key: 7333822 · Received March 13, 2018

Report

Report Number
7333822
Event Type
Malfunction
Date Received
March 13, 2018
Date of Event
February 19, 2018
Report Date
February 27, 2018
Manufacturer
BARD ACCESS SYSTEMS, INC.
Product Code
LJS
Product Problem
Yes
Report Source
User Facility report
Reporter Location
IL, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

PICC LINE PLACED WITH SHERLOCK 3CG TECHNOLOGY. SHERLOCK CONFIRMED PLACEMENT OF PICC IN SVC (SUPERIOR VENA CAVA). PATIENT DEVELOPED ARRHYTHMIAS AFTER PICC LINE PLACED. MD ORDERED MULTIPLE TESTS TO FIND SOURCE OF ARRHYTHMIA OVER 2-3 DAYS. CT RESULT SHOWED CATHETER IN RIGHT ATRIUM. PICC LINE WAS PULLED BACK 3CM AND PLACEMENT VERIFIED BY XRAY. PATIENT WAS NOT ON TELEMETRY BEFORE PICC WAS PLACED. PATIENT WAS NOTED TO BE IN NORMAL SINUS RHYTHM PER ECG BARD DEVICE. PATIENT WAS NOTED TO BE IN NORMAL SINUS RHYTHM WHILE UNDER THE CARE OF THE VASCULAR ACCESS RN. ADDITIONAL TESTS REQUIRED DUE TO ARRHYTHMIA AFTER SHERLOCK CONFIRMED PICC PLACEMENT: GATED CTA, CXR, ECHO THE PATIENT WAS STARTED CARDIZEM. NO HEPARIN (ANTICOAGULANT). THE PICC CATHETER WAS SECURED WITH A STAT-LOCK AND DRESSING (PER PROTOCOL). MIGRATION DID NOT OCCUR PER THE KNOWLEDGE OF THE VASCULAR ACCESS RN. BOTH THE SHERLOCK AND ECG CONFIRMATION TECHNIQUES WERE UTILIZED TO CONFIRM PICC PLACEMENT. PICC REMAINED IN PLACE. NO OTHER KNOWN PROBLEM SUCH AS THIS HAS OCCURRED SINCE THE INITIAL IMPLEMENTATION OF THE 3CG/ECG CONFIRMATION SYSTEM. "I HAD NO DIFFICULTY WITH PLACEMENT AT ALL. THE PATIENT DID HAVE A SPINAL CORD STIMULATOR IN PLACE WITH ELECTRODES IN HIS UPPER THORACIC SPINE (THE BATTERY OF THE DEVICE WAS DEAD, SO THE DEVICE WAS OFF). THE CATHETER WAS ADVANCED UNTIL THE P-WAVE SPIKED AND TURNED GREEN. NO NEGATIVE DEFLECTION WAS EVER NOTED. NORMAL SINUS RHYTHM CONTINUED THROUGHOUT PLACEMENT; NO ARRHYTHMIAS OR ECTOPY NOTED. NO COMPLAINTS OR SYMPTOMS NOTED BY THE PATIENT DURING OR AFTER PLACEMENT AS ASSESSED BY MYSELF", VASCULAR ACCESS RN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
176933 SHERLOCK 3CG TIP LOCATION CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS, INC. REBY0838

Patients

Seq Age Sex Outcome Treatment
1 43 YR Other NO OTHER THERAPIES| SHERLOCK SITE-RITE VISION SYSTEMMEDTRONIC SPINAL