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

Catalog Number	9-TV45X45-12F-080
Medical Device Problem Codes	Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
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 a 12f amplatzer torqvue 45x45 delivery sheath was selected for a procedure on (b)(6) 2024.During the procedure it was noted that the delivery system could not be advanced through the atrial septum and into the left atrium.The delivery system was removed from the patient and inspected.It was noted that the dilator had split.The user realized he had advanced the delivery system over a non-abbott floppy j-wire and not the requested non-abbott super stiff guidewire.The lab tech had not exchanged the wires.The user believed the dilator split from crossing the delivery system over the wrong wire.The patient remained hemodynamically stable throughout the procedure.There were no adverse effects to the patient.The patient status was stable.
Additional Manufacturer Narrative
It was reported that during the procedure it was noted that the delivery system could not be advanced through the atrial septum and into the left atrium.The delivery system was removed from the patient and was noted that the dilator had split.There were no adverse effects to the patient.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 history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Two images from field confirmed the reported dilator tip split.Information from field indicated that the user realized the delivery system was advanced over a non-abbott floppy j-wire and not the requested non-abbott super stiff guidewire which was believed to have caused dilator split from crossing the delivery system over the wrong wire.However, the exact cause of the reported incident could not be conclusively determined.There were no complaints associated with any other devices from the lot.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: 20523144
• Report Number: 2135147-2024-05275
• Device Sequence Number: 7969368
• Product Code: DQY
• UDI-Device Identifier: 05415067025883
• UDI-Public: (01)05415067025883(17)260930(10)10019421
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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: 09/30/2026
• Device Catalogue Number: 9-TV45X45-12F-080
• Device Lot Number: 10019421
• 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: 10/01/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC FLOPPY J-WIRE
• Patient Sex: Unknown