PORTA-CATH N/A 21-4000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-08-25 for PORTA-CATH N/A 21-4000 manufactured by Pharmacia Deltec.

Event Text Entries

[15035751] A porta-cath was inserted on 12/26/91. On 7/16/92 a fragment of the porta-cath was seen during a routine chest x-ray. Percutaneous removal long porta-cath fragment from the peripheral pulmonary artery of the right superior vena cava was performed. The porta-cath was inserted a lagrange memoral hospital. The subsequent cxr was done at hinsdale hospital as was removal of the fragment. Lagrange memorial was not notified of the problem until 8/5/92device labeled for single use. Patient medical status prior to event: unknown. 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 not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1207
• MDR Report Key: 1207
• Date Received: 1992-08-25
• Date of Report: 1992-08-07
• Date of Event: 1992-07-16
• Date Facility Aware: 1992-07-16
• Report Date: 1992-08-07
• Date Reported to FDA: 1992-08-07
• Date Reported to Mfgr: 1992-08-07
• Date Added to Maude: 1992-09-02
• 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: PORTA-CATH
• Generic Name: N/A
• Product Code: LKG
• Date Received: 1992-08-25
• Model Number: N/A
• Catalog Number: 21-4000
• Lot Number: 18288A
• ID Number: N/A
• Operator: OTHER CAREGIVERS
• Device Availability: Y
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 1155
• Manufacturer: PHARMACIA DELTEC

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-08-25