CORDIS LONG SHEATH SET, 7 FRENCH 501-616A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-09-14 for CORDIS LONG SHEATH SET, 7 FRENCH 501-616A manufactured by Cordis.

Event Text Entries

[16784134] Patient was to undergo a diagnostic mycardial biopsy. A guidewire was inserted into the right femoral vein and the cordis long sheath was inserted over the guidewire. After removal, under fluoroscopy, part of the sheath was noted to be in the pulmonary artery. Attempts to remove the guidewire with a retriever set were unsuccessful, the sheath fragmented into three pieces. Surgical consult was obtained and surgery to remove the foreign body was recommended. The surgery required placing the patient on cardiopulmonary bypass. The three pieces of the sheath were eventially removed from the left lung, however, the patient could not be weaned off the bypass machine and expireddevice labeled for single use. Patient medical status prior to event: fair 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, visual examination. Results of evaluation: other. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: maybe. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1386
• MDR Report Key: 1386
• Date Received: 1992-09-14
• Date of Report: 1992-09-09
• Date of Event: 1992-09-04
• Date Facility Aware: 1992-09-04
• Report Date: 1992-09-09
• Date Reported to FDA: 1992-09-09
• Date Reported to Mfgr: 1992-09-04
• Date Added to Maude: 1992-09-29
• 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: CORDIS LONG SHEATH SET, 7 FRENCH
• Generic Name: LONG SHEATH
• Product Code: EYT
• Date Received: 1992-09-14
• Catalog Number: 501-616A
• Lot Number: UNKNOWN
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1329
• Manufacturer: CORDIS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1992-09-14