QUINTON CATHETER *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-05-17 for QUINTON CATHETER * manufactured by Quinton Instrument Co.

Event Text Entries

[152388] Reason for report: the quinton catheter was placed on right femoral artery. Right femoral vein quinton catheter was placed by a physician for plasmapheresis. Two days later, plasmapheresis was done. Right thigh noted to be swollen and painful to touch from groin site to midthigh area. The pt complained of severe pain in right thigh to the legs. A urologist examined the pt and ordered arterial blood gas. Blood was aspirated from the quinton catheter and found to be conclusive for arterial blood. Quinton removal required surgical intervention. But the pt opted to have the procedure performed at a nearby community hosp. Plan of action: 1. Medical education dept to have a refresher course or in-service in technique of inserting vascular device for dialysis or plasmapheresis. Dialysis, plasmapheresis, icu nurses and relevent medical staff members are to attend. 2. Recommended the use of new arrow double or triple lumen dialysis catheter. 3. Recommended that an abg be done after placement of femoral dialysis catheter to confirm placement in the vein rather than the artery.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1018926
• MDR Report Key: 278304
• Date Received: 2000-05-17
• Date of Report: 2000-05-11
• Date of Event: 2000-05-06
• Date Added to Maude: 2000-05-22
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: QUINTON CATHETER
• Generic Name: *
• Product Code: LFK
• Date Received: 2000-05-17
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 269385
• Manufacturer: QUINTON INSTRUMENT CO
• Manufacturer Address: 3303 MONTE VILLA PKWY BOTHELL WA 980218906 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2000-05-17