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

Model Number PIKA

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  Injury  

Manufacturer Narrative

The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported that during a case involving the use of a pika percutaneous insertion kit it was noted that when the wire was being removed, it coiled upon itself and resistance was felt.The catheter and wire were removed and the tips appeared to be intact.Later, chest x-ray identified a suspicious radiopaque item.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.The complaint unable to be confirmed.Investigation is limited because the product was not returned and no medical records or images were provided.The dhr review was performed by manufacturer biomerics and no abnormalities or ncrs were found.A definitive root cause for the removal difficulty could not be conclusively determined, however it may be related to use error or procedural factors.Based on the information available, a manufacturing/supplier defect has not been confirmed.

• Brand Name: PERCUTANEOUS INSERTION KIT-ARTERIAL
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 14686847
• MDR Text Key: 294870475
• Report Number: 2015691-2022-06185
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: PIKA
• Device Lot Number: 128276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2022
• Date Device Manufactured: 12/06/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other