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

Model Number	9-TV45X45-12F-080
Medical Device Problem Codes	Positioning Problem (3009); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a 20mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 12f amplatzer torqvue 45x45 delivery sheath.During procedure, the doc's sheath came out of the appendage and accidentally went across mitral valve while in ball and hit the mitral annulus multiple times.The first deployment was so deep that it wasn't seen well on imaging.There were multiple redeployments and a new 18mm amplatzer amulet left atrial appendage occluder was chosen.During the first deployment of the second device, when the disc was deployed the lobe jumped up more proximally.The doc redeployed twice and they left a good implant.After release, a pericardial effusion was noted that grew bigger.A pericardiocentesis was performed and removed 458ccs of blood.The patient was reported stable.
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of a positioning problem was reported.A returned device assessment could not be performed as the device was not returned for analysis.Information from the field indicated he first deployment was so deep that it wasn't seen well on imaging.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Based on the available information and cine review, the cause for the reported positioning problem could not be determined.It is possible that procedural circumstances (imaging difficulties) contributed to the event, however this cannot be determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2025, a 18mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 12f amplatzer torqvue 45x45 delivery sheath.During procedure, the doc's sheath came out of the appendage and accidentally went across mitral valve while in ball, and hit the mitral annulus multiple times.The first deployment was so deep that it wasn't seen well on imaging.There were multiple redeployments and a new 20mm amplatzer amulet left atrial appendage occluder was chosen with the same delivery system.During the first deployment of the second device, when the disc was deployed the lobe jumped up more proximally.The doc redeployed twice and they left a good implant.After release, a 16mm circumferential, but more localized posterior pericardial effusion was noted that grew bigger.A cardiac tamponade was also noted.A pericardiocentesis was performed and removed 458ccs of blood.The patient was reported stable.

• 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: 23497994
• Report Number: 2135147-2025-06465
• Device Sequence Number: 8993383
• Product Code: DQY
• UDI-Device Identifier: 05415067025883
• UDI-Public: (01)05415067025883(17)280531(10)10903086
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K163000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 02/03/2026

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 Model Number: 9-TV45X45-12F-080
• Device Catalogue Number: 9-TV45X45-12F-080
• Device Lot Number: 10903086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2025
• 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: 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH, 9-TV4
• Patient Age: 73 YR
• Patient Sex: Male