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

Model Number SEPTAL OCCLUDER

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Premature Separation (4045)

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

Event Date 04/13/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2023, a 12f trevisio delivery system was selected to implant a 32 mm amplatzer septal occluder.During the procedure, the device was completely released from the cable while not intended, deploying the device prematurely in the left atrium.It needed to be snared and removed from the patient.The physician alleged that over torquing of the delivery catheter to set the septal occluder into position caused the delivery cable to unscrew from the device prematurely.There was no device implanted.The patient is stable.

Manufacturer Narrative

An event of a device detaching from a delivery cable and deploying prematurely in the left atrium was reported.A returned device inspection, to rule out any device-related causes, could not be performed as the device was not returned for analysis.Information from field indicated that the physician believed that over torqueing of the delivery catheter to set the septal occluder into position caused the delivery cable to unscrew from the device prematurely.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.H6 medical device problem code: code 4045 removed.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16890873
• MDR Text Key: 314804914
• Report Number: 2135147-2023-01992
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010236
• UDI-Public: 00811806010236
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: SEPTAL OCCLUDER
• Device Catalogue Number: 9-ASD-032
• Device Lot Number: 6515388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 71 KG