MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR INTRO-FLEX PERCUTANEOUS SHEATH; INTRODUCER, CATHETER

Model Number I300F85

Device Problem Break (1069)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/02/2022

Event Type  malfunction  

Manufacturer Narrative

One introducer was received by our product evaluation laboratory for a full examination.The report of leakage issue was confirmed.Leak testing was performed, leakage was observed from hub.Examination of the valve internal components found that the duckbill valve was torn.The torn piece of the duckbill valve was not returned.The wiper gasket was found to be in good condition.No other visible damage or leakage was observed from the returned unit.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

As reported, when inserting the sheath of this introducer during a redo coronary artery bypass graft (cabg) surgery, 10-15 ml of blood leakage at the hemostasis valve and blood backflow was noticed.The introducer was replaced using the same guidewire already inserted to solve the issue.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

Based on further engineering investigation, a leak test is performed to all the units as part of the manufacturing process.The instruction for use (ifu) were reviewed and it contains instructions on how to properly place and assemble the introducer.The manufacturing records were reviewed and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: INTRO-FLEX PERCUTANEOUS SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 15065942
• MDR Text Key: 304704716
• Report Number: 2015691-2022-06874
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2023
• Device Model Number: I300F85
• Device Lot Number: 63783022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male