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

Catalog Number	9-TV45X45-12F-080
Medical Device Problem Codes	Product Quality Problem (1506); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
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 on (b)(6) 2024, a 12f amplatzer torqvue 45x45 delivery sheath (lot 9114597) was chosen for procedure.It was noted that the patient had a tough atrial septum which was difficult to cross.There was resistance during the transseptal puncture, and it was challenging to advance the delivery system across the septum.A non-abbott catheter was utilized to balloon the septum to 6mm.The tip of the dilator of the sheath became frayed in an attempted septal crossing, so the device was replaced with a new 12f amplatzer torqvue 45x45 delivery sheath (lot 9137769).The physician did not believe to be in "out of box" condition, and the physician reported that the delivery sheath looked "beaten up." the device was attempted to be used but resulted in the catheter looking damaged and was unable to be advanced.The device was replaced with another 12f amplatzer torqvue 45x45 delivery sheath (lot 9138439).There was mild difficulty advancing the delivery sheath, and it was reported that there was a slight "hitch" point where the dilater tapers into the sheath tip.However, this device was able to be successfully advanced and used to implant an amplatzer amulet left atrial appendage occluder successfully.The entire process of crossing the septum into the left atrium took 20 minutes.The physician stated that the difficulty crossing the atrium was likely due to patient's septum and tissue, but the physician also complained that the transition between the dilator and the sheath was not as smooth as it could be.It felt like the sheath was getting stuck at the septum at this transition point between the dilator and the sheath.There were no adverse patient effects.The patient status was stable.
Additional Manufacturer Narrative
An event of an difficult to advance through patient anatomy, material deformation, and product quality problem (beat up) 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, including specification for radial force.Reportedly, it was noted that the patient had a tough atrial septum which was difficult to cross.There was resistance during the transseptal puncture, and it was challenging to advance the delivery system across the septum.The physician did not believe to be in "out of box" condition and reported that the delivery sheath looked "beaten up.".The device was attempted to be used but resulted in the catheter looking damaged and was unable to be advanced.Therefore, a new delivery system was used.Per case detail, the physician stated that the difficulty crossing the atrium was likely due to patient's septum and tissue (patient's septal composition).Based on the information received, the cause of the reported difficult to advance appears to be related to patient's anatomy.The reported material deformation and product quality problem could not be determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 19393788
• Report Number: 2135147-2024-02386
• Device Sequence Number: 6776364
• Product Code: DQY
• UDI-Device Identifier: 05415067025883
• UDI-Public: (01)05415067025883(17)260630(10)9137769
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 07/03/2024

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: 9137769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2023
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 103 KG