MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS PERCUTANEOUS INSERTION KIT-ARTERIAL; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Lot Number 128276

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/22/2022

Event Type  malfunction  

Event Description

When the wire was being removed, it coiled upon itself and resistance was felt.Catheter and wire were removed and tips appeared to be intact.Later chest x-ray identified suspicious radiopaque item.Fda safety report id # (b)(4).

• Brand Name: EDWARDS PERCUTANEOUS INSERTION KIT-ARTERIAL
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; irvine CA 92614
• MDR Report Key: 14257502
• MDR Text Key: 290560931
• Report Number: MW5109464
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• 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: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 128276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 33 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White