PHARMACIA-DELTEC PORT-A-CATH UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-11 for PHARMACIA-DELTEC PORT-A-CATH UNKNOWN manufactured by Pharmacia-deltec.

Event Text Entries

[11784] Patient had a port-a-cath placed on 1/8/93 and was receiving a regimen of cytoxan, adriamycin and 5-fu via chemotherapy regimen. Between sessions, she noted abnormalities with intermittent palpitations. She was admitted on 4/7/93 and a chest x-ray confirmed that the distal aspect of the catheter had apparently sheared and embolized the position consistent with a right atrium, right ventricle on the pa and lateral x-ray, best seen on the lateral view.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 16746
• MDR Report Key: 16746
• Date Received: 1994-08-11
• Date of Report: 1994-03-31
• Date of Event: 1993-04-07
• Date Facility Aware: 1994-03-23
• Report Date: 1994-03-31
• Date Reported to Mfgr: 1994-03-31
• Date Added to Maude: 1994-10-12
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PHARMACIA-DELTEC PORT-A-CATH
• Generic Name: PORT-A-CATH
• Product Code: LKG
• Date Received: 1994-08-11
• Model Number: UNKNOWN
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 3 MO
• Implant Flag: Y
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 16679
• Manufacturer: PHARMACIA-DELTEC
• Manufacturer Address: 1265 GREY FOX ROAD ST. PAUL MN 551126967 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	1994-08-11