MAUDE Adverse Event Report: W. L. GORE ASSOCIATES, INC. GORE CARDIOFORM SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number GSX0030A

Device Problems Defective Component (2292); Activation Failure (3270)

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

Event Date 04/20/2022

Event Type  malfunction  

Event Description

Patient presented to cath lab for atrial septal defect repair.Doctor opened and inserted a 30mm and 32mm device but was unable to safely deploy the devices in the defect.Both devices were removed.He decided to upsize to a 37mm device.The staff opened the device, and it was defective.The supplier comped us for the defective device.An additional 37mm device was opened and inserted into the patient.The device was deployed, and the procedure was completed without any complications.Due to the operational waste policy 3 devices were opened and uses as indented but ultimately 2 of the 3 devices were removed.The patient should be charged for all 3 devices per policy.Manufacturer response for transcatheter septal occluder, gore cardioform septal occluder (per site reporter) vendor reimbursed for product.

• Brand Name: GORE CARDIOFORM SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): W. L. GORE ASSOCIATES, INC.; 3250 w. kiltie; p.o. box 2400; flagstaff AZ 86005
• MDR Report Key: 14630930
• MDR Text Key: 293563741
• Report Number: 14630930
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: GSX0030A
• Device Catalogue Number: GSX0030A
• Device Lot Number: 24375377
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Sex: Male
• Patient Weight: 149 KG