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

Model Number I300F85

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2021

Event Type  malfunction  

Event Description

As reported, before use in patient, the packaging of this introducer was found damaged.Sterile barrier was compromised.There was no patient involved.The device was available for evaluation.

Manufacturer Narrative

One introducer was received by our product evaluation laboratory for a full evaluation.The report of seal issue was confirmed.The packing tray was received partially unsealed.The top of the tyvek lid remained sealed.Adhesive was not visible along the sealing area.The adhesive transfer appeared incomplete.There was no other visible abnormality to the package.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.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.

Manufacturer Narrative

Further investigation was completed by the engineers at the manufacturing site.This condition could be related to both supplier and manufacturing inspection process.Therefore, the supplier has been notified in order to perform an investigation to avoid the recurrence of this issue.Additionally, an acknowledgment was provided to the manufacturing personnel regarding this condition.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: EDWARDS PERCUTANEOUS SHEATH INTRODUCER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco, puerto rico
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco, puerto rico
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 13202839
• MDR Text Key: 285000218
• Report Number: 2015691-2022-03300
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2023
• Device Model Number: I300F85
• Device Lot Number: 63738451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2021
• 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