PORT-A-CATH TITANIUM VENOUS 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 1993-06-11 for PORT-A-CATH TITANIUM VENOUS 21-4000 manufactured by Pharmacia Deltec.

Event Text Entries

[2838] On march 29, 1993, a port-a-cath of the above mentioned model was removed from a patient (after having been implanted in january of 1992) and found to be fractured. The tip had broken off and was lodged in the pulmonary artery from which it was sucessfully retreived by one of our vascular surgeons. The piece which had broken off was 5" (125mm) long. The surgeons felt that it had broken at some earlier time and had been dislodged to the pulmonary artery prior to surgery. The surgical procedure to remove it had been done due to patient experiencing dysfunction of the port-a-cath. Also, the patient no longer needed itdevice 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: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: yes. 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: 4985
• MDR Report Key: 4985
• Date Received: 1993-06-11
• Date of Report: 1993-04-02
• Date of Event: 1993-03-29
• Date Facility Aware: 1993-03-29
• Report Date: 1993-04-02
• Date Reported to Mfgr: 1993-03-30
• Date Added to Maude: 1993-06-22
• 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
• Product Code: LLD
• Date Received: 1993-06-11
• Model Number: TITANIUM VENOUS
• Catalog Number: 21-4000
• Lot Number: 18170A
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 4688
• Manufacturer: PHARMACIA DELTEC

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-06-11