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

Lot Number 63505975

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 05/18/2021

Event Type  malfunction  

Event Description

When the edwards tavr sheath was removed from the patients groin it was noted that a portion of the tip of the sheath was missing.Fda safety report id# (b)(4).

• Brand Name: EDWARDS LIFESCIENCES ESHEATH INTRODUCER SET
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC.
• MDR Report Key: 12008113
• MDR Text Key: 256739027
• Report Number: MW5101903
• Device Sequence Number: 1
• Product Code: DYB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2022
• Device Lot Number: 63505975
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR