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

Model Number 914ES

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/16/2020

Event Type  malfunction  

Event Description

While attempting removal of a 14fr x 36 cm edwards esheath introducer set, ref # 914es; the tip was retained in the patient's left leg.Multiple attempts at percutaneous removal were unsuccessful.

• 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: 10710628
• MDR Text Key: 212281948
• Report Number: 10710628
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103193985
• UDI-Public: (01)00690103193985
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/01/2020,09/30/2020

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: No Information
• Device Model Number: 914ES
• Device Catalogue Number: 914ESA
• Device Lot Number: 62965495
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/01/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1