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

Catalog Number	9-TDS-09F45-80
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	07/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical information: crd_806 - pfo occluder pas, patient site id: (b)(6) (r852733701).It was reported that on 15 july 2024, a 9f amplatzer talisman delivery system was selected for procedure.There was no performance issues with the 9f amplatzer talisman delivery system.On the same day it was noted post-discharged, that the patient had soaking blood at the access site of the delivery system.The patient returned to the emergency department and pressure was applied to the bleeding closure/access site for 5 minutes.The patient had an international normalized ratio of 1.1.The decision was made to place pressure dressing and a saline bag over the bleeding closure/access site to stop the bleeding.An ultrasound was performed to rule out possible of pseudoaneurysm.There was no blood transfusion required.There is no allegation of malfunction against the delivery system or procedure.The patient was discharged at the time of report.
Additional Manufacturer Narrative
An event bleeding at access site 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 specifications.Based on the information received, a cause of the reported incident could not be conclusively determined.Bleeding at the access site is a possible outcome of the procedure per the instructions for use.There was no allegation of malfunction against the delivery system or procedure.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 19994005
• Report Number: 2135147-2024-03991
• Device Sequence Number: 7076040
• Product Code: DQY
• UDI-Device Identifier: 05415067033369
• UDI-Public: (01)05415067033369(17)261231(10)10138765
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 08/15/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 9-TDS-09F45-80
• Device Lot Number: 10138765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White