MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA (CVD) AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-ASD-017

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On an unknown date, a 9 mm amplatzer septal occluder was selected for implant.During device preparation, exposed threads were seen in the device packaging.The patient remained hemodynamically stable but there was a significant delay in the procedure as a replacement was borrowed from another centre.The procedure was successfully completed.

Manufacturer Narrative

Additional information sections: d10, h2, h3, h6, h10.The reported event of a protruding polyester thread was confirmed, however the knot met dimensional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The sewing knots that are seen above the nitinol wires are considered a normal and acceptable characteristic of the occluder.Although the occluder was determined to meet specifications, a capa was initiated for further investigation on the protruding threads, per internal procedures.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (CVD); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• MDR Report Key: 10195260
• MDR Text Key: 196775358
• Report Number: 3008452825-2020-00320
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010144
• UDI-Public: 00811806010144
• Combination Product (y/n): N
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 9-ASD-017
• Device Catalogue Number: 9-ASD-017
• Device Lot Number: 6791355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 06/25/2020
• Supplement Dates Manufacturer Received: 08/15/2020
• Supplement Dates FDA Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention