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

Catalog Number	9-TV45X45-12F-080
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.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 amplatzer amulet was chosen for implantation utilizing a 12f torqvue delivery sheath.Once the sheath was inserted into the patient, a split was observed.The device was removed and a replacement delivery system was used to complete the procedure.There was no patient consequences.
Additional Manufacturer Narrative
An event of split observed upon inserting sheath into the patient was reported.A returned device inspection, to rule out any device-related causes, could not be performed as the device was not returned for analysis.The device was removed and a replacement delivery system was used to complete the procedure.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, the cause of the reported incident could not be conclusively determined.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: 19288316
• Report Number: 2135147-2024-02113
• Device Sequence Number: 21017738
• Product Code: DQY
• UDI-Device Identifier: 05415067025883
• UDI-Public: (01)05415067025883(17)260630(10)9146053
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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: 06/30/2026
• Device Catalogue Number: 9-TV45X45-12F-080
• Device Lot Number: 9146053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2023
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Race: White