MAUDE Adverse Event Report: ABBOTT LABORATORIES AMPLATZER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-ASD-009

Device Problem Material Deformation (2976)

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

Event Date 03/18/2022

Event Type  malfunction  

Event Description

When the delivery catheter of the amplatzer septal occluder was introduced into the femoral sheath the tip of the delivery catheter folded onto itself.The delivery catheter was removed and replaced with a new product.There was no harm to the patient.

• Brand Name: AMPLATZER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT LABORATORIES; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 14591857
• MDR Text Key: 293265085
• Report Number: 14591857
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-ASD-009
• Device Catalogue Number: 9-ASD-009
• Device Lot Number: 7584699
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other