LIFEPORT CATHETER LPS 5513

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-02 for LIFEPORT CATHETER LPS 5513 manufactured by Strato Medical Corporation.

Event Text Entries

[19140707] Recent chest x-ray shows fracture of the catheter in the subclavian vein from the last surgery a year ago. Patient was admitted to the surgery again for removal of this broken catheter. Under iv sedation, a small incision was made over the catheter just beneath the clavicle. The catheter was withdrawn, and it was noted that the fracture distal tip, approx. 3cm, remained in the subclavian vein without dislodgement. 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. Invalid data - regarding evaluation by user after event. Method of evaluation: a device from same lot was evaluated, visual examination. Results of evaluation: other. Conclusion: invalid data. Certainty of device as cause of or contributor to event: yes. Corrective actions: device discarded. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 7503
• MDR Report Key: 7503
• Date Received: 1994-02-02
• Date of Report: 1993-11-08
• Date of Event: 1993-10-08
• Date Facility Aware: 1993-10-08
• Report Date: 1993-11-08
• Date Reported to Mfgr: 1993-10-08
• Date Added to Maude: 1994-04-26
• 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: LIFEPORT CATHETER
• Generic Name: CATHETER
• Product Code: LKG
• Date Received: 1994-02-02
• Catalog Number: LPS 5513
• Lot Number: UNKNOWN
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 7182
• Manufacturer: STRATO MEDICAL CORPORATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1994-02-02