MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS ESHEATH INTRODUCER SET; INTRODUCER, CATHETER

Model Number 916ES

Device Problem Material Frayed (1262)

Patient Problem No Information (3190)

Event Date 03/09/2017

Event Type  malfunction  

Event Description

Upon extracting sheath, doctor noticed fraying on the end of the sheath.

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 6416731
• MDR Text Key: 70325282
• Report Number: 6416731
• Device Sequence Number: 0
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/02/2017
• Device Model Number: 916ES
• Device Catalogue Number: 916ESA
• Device Lot Number: 60526037
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR