PORT-A-CATH CENTRAL VENOUS CATHETER 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 1992-07-31 for PORT-A-CATH CENTRAL VENOUS CATHETER N/A 21-4000 manufactured by Pharmacia Deltec Inc..

Event Text Entries

[2497] 30 year old female patient with advanced carcinoma of breast undergoing chemotherapy via port-a-cath intravenous catheter in left subclavian vein. Presented at hospital with progressive pulmonary metastases. Found port-a-cath had severed with distal end floating into right heart. Three attempts to remove severed portion unsuccessful. Final attempt on january 25, 1992, successful. Ecri reports on evaluation indicate catheter compressed by clavicle and rib pinching it off. Device labeled for single use. Patient medical status prior to event: satisfactory 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: expected wear/deterioration, telemetry failure, inherent risk of procedure. Conclusion: device failure directly contributed to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3414
• MDR Report Key: 3414
• Date Received: 1992-07-31
• Date of Report: 1992-03-17
• Date of Event: 1992-01-25
• Date Facility Aware: 1992-03-12
• Report Date: 1992-03-17
• Date Reported to FDA: 1992-03-17
• Date Reported to Mfgr: 1992-03-17
• Date Added to Maude: 1993-04-19
• 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 CENTRAL VENOUS CATHETER
• Generic Name: CATHETER, INTRAVENOUS
• Product Code: LKG
• Date Received: 1992-07-31
• Model Number: N/A
• Catalog Number: 21-4000
• Lot Number: 18094A
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 3180
• Manufacturer: PHARMACIA DELTEC INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-31