PORT-A-CATH 21-4003

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-10-04 for PORT-A-CATH 21-4003 manufactured by Pharmacia Deltec.

Event Text Entries

[20055480] It was discovered on chest x-ray that the distal tip of the port-a-cath was freely floating in the left ventricle. It was removed successfully by a raiologist in the o. R. Via the right femoral vein approach. Device labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: telemetry failure, none or unknown, none or unknown, port. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6720
• MDR Report Key: 6720
• Date Received: 1993-10-04
• Date of Report: 1993-02-02
• Date of Event: 1993-01-28
• Report Date: 1993-02-02
• Date Added to Maude: 1993-10-13
• 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: 0
• Initial Report to FDA: 0
• 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: PORT-A-CATH
• Generic Name: PORT-A-CATH
• Product Code: LKG
• Date Received: 1993-10-04
• Model Number: 21-4003
• Lot Number: 18849A
• Operator: OTHER
• Device Availability: Y
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 6404
• Manufacturer: PHARMACIA DELTEC

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-10-04