PORT-A-CATH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-01-13 for PORT-A-CATH manufactured by Pharmacia Deltec, Inc..

Event Text Entries

[184] On 10/7/91, a port-a-cath was placed in a 40 year old female with ovarian carcinoma for access for chemotherapy as an out patient. Post procedure chest x-ray confirmed appropriate position. This was re-confirmed by chest x-ray on 11/8/91. The port-a -cath was accessed one week after insertion. On 11/19/91 and 11/20/91 dificulty was encountered by oncology staff in physician's office. The surgeon was notified by oncologist and patient seen in emergency department. A chest x-ray revealed intravascular portion of cath had fractured from extravascular and appeared in (r) heart at tricuspid valve. The patient was asymptomatic. The fragment removed via transvenous fluoroscopic technique. The patient tolerated procedure well and was dischaarged home with no apparent ill effectsdevice 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. Results of evaluation: invalid data. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 372
• MDR Report Key: 372
• Date Received: 1992-01-13
• Date of Report: 1991-12-03
• Date Facility Aware: 1991-11-21
• Report Date: 1991-12-03
• Date Reported to FDA: 1991-12-03
• Date Reported to Mfgr: 1991-11-21
• Date Added to Maude: 1992-04-21
• 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: 1992-01-13
• Lot Number: 17994A
• ID Number: 21-400
• Device Availability: Y
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 366
• Manufacturer: PHARMACIA DELTEC, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-01-13