VITAL-PORT

Report

Report Number: 2522007-2008-00001
Event Type: Injury
Date Received: March 27, 2008
Date of Event: February 28, 2008
Report Date: March 17, 2008
Manufacturer: COOK VASCULAR INC.
Product Code: LJT
PMA / PMN Number: K931586
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

HISTORY: A VITAL-PORT SYSTEM WAS RETURNED DUE TO A REPORTED FRACTURED CATHETER. ANALYSIS: AN INVENTORY OF THE RETURNED SYSTEM INCLUDED THE PORT BODY, ATTACHED LOCK AND LOCKING SLEEVE AND TWO SEGMENTS OF CATHETER (ATTACHED: 10CM, DETACHED: 12 CM) A VISUAL INSPECTION OF THE FRACTURE AREA REVEALED THAT THE CROSS SECTION OF THE SILICONE CATHETER WAS DEFORMED INTO AN ELLIPTICAL SHAPE. THE SURFACE OF THE FRACTURED AREA POSSESSED A GRAINY TEXTURE AND WAS IRREGULAR IN NATURE. CONCLUSION: THE FRACTURE OF THE CATHETER WAS LIKELY DUE TO REPEATED COMPRESSION BETWEEN TWO RIGID BODIES. CATHETER FRACTURE IS LISTED AS ONE OF THE POTENTIAL COMPLICATIONS IN THE VITAL-PORT "SUGGESTED INSTRUCTION FOR USE" (PACKAGE INSERT). AS PER THE "SUGGESTED INSTRUCTION FOR USE" (PACKAGE INSERT), THE "CEPHALIC VEIN DOES NOT FOLLOW AS STRAIGHT A PATH TO THE SUBCLAVIAN VEIN AS THE BASILICA VEIN" WHICH MAY CAUSE ADD'L STRESS ON THE CATHETER. ALSO, "TO ALLOW FOR BODY MOVEMENT, THE CATHETER SHOULD NOT BE IMPLANTED WITH TENSION..." FINALLY, IT IS SUGGESTED THAT THE VITAL-PORT BE ANCHORED TO THE FASCIA WITH NON ABSORBABLE SUTURES.

Description of Event or Problem · 1

AS REPORTED, "PHYSICIAN REALIZED A BAD DROPPING OF MEDICINE ADMINISTRATION; BY X-RAY IT REVEALED THE CATHETER WAS CUT. THE CUT CATHETER WAS IN THE ATRIUM DEXTRUM AND WAS RETRIEVED BY USING THE EXTRACTING CATHETER FROM THE FEMORAL VEIN."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VITAL-PORT	VASCULAR ACCESS SYSTEM	LJT	COOK VASCULAR INC.	IP-S5118-N	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization