MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TALISMAN DELIVERY SHEATH; CATHETER, PERCUTANEOUS

Catalog Number	9-TDS-09F45-80
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	01/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2024, a 30-25mm amplatzer talisman pfo occluder was chosen for a patent foramen ovale (pfo) closure using a 9f amplatzer talisman delivery sheath.Heparin was administrated at the beginning of the procedure.During procedure, a thrombus was noted on the distal side of the delivery sheath.The thrombus was over 1cm and fiber-like shape.The sheath was in the patient for 2-3 minutes.The physician was able to aspire the sheath but the right side of the device had a bulbous shape.The physician flushed the device after the aspiration of the thrombus but there was a small part of thrombus that couldn't be removed.A decision was taken to replace the device.The deformed device was never released from the delivery cable while inside the patient.There was no report of any interaction with cardiac structures during deployment and no report of any angulation/kink noticed with the delivery system.A new 30mm amplatzer multi-fenestrated septal occluder - cribriform was chosen and completed the procedure.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure.The patient had been compliant with the prescribed anticoagulant.The patient was reported stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of fiber-like shaped thrombus on distal side of the delivery sheath was reported.Also reported that the thrombus was over 1 cm.A returned device assessment could not be performed as the device 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.Na.

• Brand Name: AMPLATZER TALISMAN 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: 18732297
• Report Number: 2135147-2024-00731
• Device Sequence Number: 17729884
• Product Code: DQY
• UDI-Device Identifier: 05415067033369
• UDI-Public: 05415067033369
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K212738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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: 03/31/2026
• Device Catalogue Number: 9-TDS-09F45-80
• Device Lot Number: 9016614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2024
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2023
• 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: Other
• Patient Age: 52 YR
• Patient Sex: Male