MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TORQVUE 45X45 DELIVERY SHEATH; CATHETER, PERCUTANEOUS

Catalog Number	9-TV45X45-12F-080
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2023, a 12f amplatzer torqvue 45x45 delivery sheath was elected to implant a device.During procedure, the physician struggled getting sheath across septum during the transseptal puncture (tsp) and did not want to administer heparin until the sheath was successfully across the septum.Heparin was not immediately given post tsp.Several minutes passed with equipment in left atrium (la) before heparin was given.The first activated clotting time (act) level was 227 seconds and did not demonstrate therapeutic levels.Additional heparin was administered, and the second act was 293 seconds.A thrombus noted in la while the physician was trying to access left atrial appendage (laa).The delivery sheath and non-abbott pigtail catheter were in the la at the time.The delivery sheath and pigtail catheter were both aspirated in attempt to remove the clot.Both the delivery sheath and the pigtail catheter were carefully removed from the patient, and thrombus was noted on the tip of the pigtail catheter.Thorough transesophageal echocardiogram (tee) imaging did not show a thrombus anywhere else in the heart or surrounding areas.The procedure was then aborted, and patient was taken to the intensive care unit (icu) for observation and to remain on a heparin drip overnight.The patient was reported as stable.
Additional Manufacturer Narrative
An event of difficulty passing sheath across septum during the transseptal puncture and thrombus in la was reported.It was reported that the delivery sheath and pigtail catheter were both aspirated in attempt to remove the clot and were removed from the patient.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER TORQVUE 45X45 DELIVERY SHEATH
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 18297509
• Report Number: 2135147-2023-05405
• Device Sequence Number: 12610355
• Product Code: DQY
• UDI-Device Identifier: 05415067025883
• UDI-Public: 05415067025883
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K163000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: 9-TV45X45-12F-080
• Device Lot Number: 8971936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 83 YR
• Patient Sex: Male