10 FRENCH SHEATH 1205-60-3700

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-02 for 10 FRENCH SHEATH 1205-60-3700 manufactured by Universal Medical Instrument Corporation.

Event Text Entries

[7522] During a ptca procedure, a 10 french sheath was inserted to left femoral artery. While the physician was inserting a catheter into the sheath, the sheath came apart at the clear hub connection. A small white plastic introducer remained in the patient and had to be immediately removed over a guidewire. In addition, two other sheaths came apart while being removed from two other patients. 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. Invalid data - regarding whether event presents imminent hazard. 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: 9838
• MDR Report Key: 9838
• Date Received: 1993-08-02
• Date of Report: 1993-07-23
• Report Date: 1993-07-23
• Date Added to Maude: 1995-01-31
• 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: 10 FRENCH SHEATH
• Product Code: EYT
• Date Received: 1993-08-02
• Catalog Number: 1205-60-3700
• Lot Number: 150006
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 9490
• Manufacturer: UNIVERSAL MEDICAL INSTRUMENT CORPORATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. No Informationnvalid Deathata	1993-08-02