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

Catalog Number	9-TDS-08F45-80
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/17/2024
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
Clinical information: crd_1032 - sh device registry, patient site id: (b)(6).It was reported that on (b)(6) 2024, an 8f amplatzer talisman delivery system was selected for procedure.At an unknown point it was noted that the patient had minor bleeding at the femoral puncture site.The decision was made to place a pressure bandage.
Additional Manufacturer Narrative
An event for patient effects of bleeding was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Based on the information received, the cause of the reported bleeding could not be conclusively determined.The reported unexpected medical intervention was a resulted of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
Subsequent the the previously filed report, additional information was received that the minor bleeding was noted post-procedure on (b)(6) 2024.The cause of the patient's minor bleeding is attributed to placement/use of the 8f amplatzer talisman delivery system.There is no allegation of malfunction against the abbott device or procedure.The patient was discharged at the time of report.

• 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: 20801123
• Report Number: 2135147-2024-06061
• Device Sequence Number: 7895005
• Product Code: DQY
• UDI-Device Identifier: 05415067033352
• UDI-Public: (01)05415067033352(17)270228(10)10245845
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 9-TDS-08F45-80
• Device Lot Number: 10245845
• 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: 11/04/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2024
• 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: Required Intervention
• Patient Sex: Female
• Patient Weight: 49 KG