FDA Adverse Event Malfunction Summary report: N

CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

MDR report key: 7107837 · Received December 12, 2017

Report

Report Number
7107837
Event Type
Malfunction
Date Received
December 12, 2017
Date of Event
December 4, 2017
Report Date
December 8, 2017
Manufacturer
MEDICAL COMPONENTS INC
Product Code
LJS
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE TEAM WAS CONCERNED ABOUT PATIENT DISCOMFORT WHEN THE PICC LINE WAS MANUALLY FLUSHED AND CALLED THE IV TEAM FOR A CONSULT AS FOLLOWS: ONE OF THE LUMENS HAS NO BLOOD RETURN. CHEST X-RAY ON THIS DAY DEMONSTRATED A DISTINCT AREA OF DISCONTINUATION OF THE PICC CATHETER IN THE REGION OF THE LEFT AXILLA. BASED ON THIS FINDING AND PATIENT EXAM WHICH SHOWED THAT THE AREA OF THE RIGHT AXILLA (LOCATION OF PICC LINE) WAS MORE SWOLLEN THAN THE LEFT THE DECISION WAS TO REMOVE THE LINE. THE IV TEAM DETERMINED THAT BEDSIDE REMOVAL WAS TOO RISKY. THE PATIENT WAS TAKEN TO THE OR THE FOLLOWING DAY FOR LINE REMOVAL AND REMEDIATION. IN THE OR, THE SURGEON PULLED OUT THE PICC LINE UNDER FLUOROSCOPY TO THE POINT OF THE DISCONTINUATION WHICH REVEALED A FRACTURE. THERE WERE SEVERAL CMS OF INTACT PICC LINE STILL IN THE VEIN. THE FRACTURED PORTION OF THE LINE WAS CUT OFF AND THREADED WITH 0.014 GUIDEWIRE THROUGH THE PORTION OF THE PICC THAT REMAINED IN THE VEIN. THE SURGEON CONFIRMED THAT IT WAS IN A GOOD POSITION. USING THE GUIDEWIRE WITH FLUOROSCOPY HE THEN REMOVED THE REMAINING PORTION OF THE PICC LINE OVER THE WIRE. IT WAS CLEAR THAT THE LINE CAME OUT COMPLETELY INTACT. IT WAS NOT CLEAR WHAT HAD CAUSED THE FRACTURE BUT THAT THE PORTION THAT WAS FRACTURED WAS 'QUITE MESSED UP': IT ALMOST LOOKED LIKE A 'SMALL GRENADE HAD EXPLODED THERE, SO I DO NOT HAVE A GOOD EXPLANATION FOR HOW IT FRACTURED' IN THAT AREA (WORDING IN ' TAKEN FROM THE SURGEONS' NOTE). NONETHELESS, WITH THE GUIDEWIRE IN PLACE WE CUT A NEW PICC LINE TO THE PROPER LENGTH AND PASSED IT OVER THE GUIDEWIRE. IT DREW AND FLUSHED. FLUOROSCOPY CONFIRMED GOOD POSITION AND THIS PICC WAS CUT TO THE LENGTH OF THE PRIOR PICC LINE, WHICH WAS IN GOOD POSITION. THE PICC LINE WAS SECURED AND A STERILE DRESSING WAS APPLIED. THE PATIENT TOLERATED THE PROCEDURE WELL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
889774 CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS MEDICAL COMPONENTS INC MJLM470

Patients

Seq Age Sex Outcome Treatment
1 1 YR