010006

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-06-22 for 010006 manufactured by Usci Division - Field Assurance.

Event Text Entries

[2928] As cardiologist was introducting venous sheath into femoral vein, a kink was evident in the mid-shaft. When physician attempted to remove sheath, the distal portion of the sheath "sheared off" with a fragment of the sheath remaining in the patient's right femoral vein. An ivc filter was placed in patient's vena cava to prevent migration of sheath fragment. Invalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding 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. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4461
• MDR Report Key: 4461
• Date Received: 1992-06-22
• Date of Report: 1992-06-22
• Report Date: 1992-06-22
• Date Added to Maude: 1993-05-25
• 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

• Generic Name: 6F HEMOQUET
• Product Code: EYT
• Date Received: 1992-06-22
• Model Number: 010006
• Catalog Number: 010006
• Lot Number: 09LB1055
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 4182
• Manufacturer: USCI DIVISION - FIELD ASSURANCE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-06-22