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

Catalog Number	9-TDS-09F45-80
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
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) 2024, a 9f amplatzer talisman delivery system was selected for use to implant an unknown sized amplatzer pfo occluder.The delivery system had difficulty inserting into the access site at the femoral area.The delivery system was removed from the patient and it was observed that the tip of the system was flared; the physician alleged that excessive force was the cause of the flaring.The tip was not torn/ripped.A new 9f amplatzer talisman delivery system was used to complete the procedure.The patient remained hemodynamically stable throughout the procedure and no clinically significant prolonged procedure was reported.No patient consequences were reported.
Additional Manufacturer Narrative
An event of difficulty inserting into the access site and material deformation was reported.The size occluder being used was not reported, so confirmation that the correct sized delivery system was used could not be done.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 available information and without the device to analyze, the cause of the reported event of difficulty inserting could not be determined.However, it was noted that excessive force was the cause of flaring.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: 19974068
• Report Number: 2135147-2024-03938
• Device Sequence Number: 17906709
• Product Code: DQY
• UDI-Device Identifier: 05415067033369
• UDI-Public: (01)05415067033369(17)260731(10)9213516
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/21/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: 9-TDS-09F45-80
• Device Lot Number: 9213516
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2023
• 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
• Patient Sex: Unknown