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

Model Number	9-TV45X45-14F-080
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Codes	Air Embolism (1697); Arrhythmia (1721)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, an 18mm amplatzer amulet occluder was successfully implanted using a 14f amplatzer torqvue 45x45 delivery sheath.During a procedure performed under conscious sedation with intracardiac echocardiography (ice), the patient presented with complex cardiac anatomy and a pre-procedural pericardial effusion measuring 1.7 mm.A pre-procedural computed tomography (ct) scan revealed a relatively large left atrial appendage (laa).While the occluder was being advanced through the delivery sheath, the patient experienced premature ventricular contractions (pvcs) and reported feeling hot, though without chest pain.Upon injecting contrast into the laa, a faint leak of contrast was observed exiting the appendage.After device deployment, suspected air bubbles were seen in the aorta via intracardiac echocardiography (ice), prompting a switch to transesophageal echocardiography (tee) and conversion to general anesthesia.Tee imaging ruled out aortic complications but confirmed the presence of bubbles within the pericardial effusion, but were not intracardiac.A hematoma was also identified and located between the aorta and the laa, external to the heart.The pvcs resolved within 15 minutes, and the effusion remained stable without enlargement.During or after the event, the patient felt hot but had no chest pain.No medical intervention or aspiration was performed.A continuous flush was attached to the delivery sheath and was shut off once the occluder reached the sheath tip.Implanting occluder proved challenging due to pectinated and shallow anatomy, with discrepancies between angiography, ice, and pre-procedural ct imaging.The dilator or guidewire was not removed too quickly or slowly, and the loader was immediately connected to the sheath after their removal.There was no hospitalization due to the event.Although the 18mm amplatzer amulet occluder appeared significantly compressed, it remained stable upon performing an additional tug test.After consultation with the attending physician, it was determined that device removal could pose additional risk to the patient.A follow-up on (b)(6) 2025, confirmed that the patient was stable and that no abnormalities were detected on the post-implant ct scan.The implanting physician believes the premature ventricular contractions were caused by potential air bubbles trapped in the sheath or device during preparation.Regarding the hematoma between the aorta and left atrial appendage, the physician was unsure if it was pre-existing, noting that (ice) imaging at the start did not provide clear visuals.
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) 2025, an 18mm amplatzer amulet occluder was successfully implanted using a 14f amplatzer torqvue 45x45 delivery sheath.During a procedure performed under conscious sedation with intracardiac echocardiography (ice), the patient presented with complex cardiac anatomy and a pre-procedural pericardial effusion measuring 1.7 mm.A pre-procedural computed tomography (ct) scan revealed a relatively large left atrial appendage (laa).While the occluder was being advanced through the delivery sheath, the patient experienced premature ventricular contractions (pvcs) and reported feeling hot, though without chest pain.Upon injecting contrast into the laa, a faint leak of contrast was observed exiting the appendage.After device deployment, suspected air bubbles were seen in the aorta via intracardiac echocardiography (ice), prompting a switch to transesophageal echocardiography (tee) and conversion to general anesthesia.Tee imaging ruled out aortic complications but confirmed the presence of bubbles within the pericardial effusion, but were not intracardiac.A hematoma was also identified and located between the aorta and the laa, external to the heart.The pvcs resolved within 15 minutes, and the effusion remained stable without enlargement.During or after the event, the patient felt hot but had no chest pain.No medical intervention or aspiration was performed.A continuous flush was attached to the delivery sheath and was shut off once the occluder reached the sheath tip.Implanting occluder proved challenging due to pectinated and shallow anatomy, with discrepancies between angiography, ice, and pre-procedural ct imaging.The dilator or guidewire was not removed too quickly or slowly, and the loader was immediately connected to the sheath after their removal.There was no hospitalization due to the event.Although the 18mm amplatzer amulet occluder appeared significantly compressed, it remained stable upon performing an additional tug test.After consultation with the attending physician, it was determined that device removal could pose additional risk to the patient.A follow-up on (b)(6), 2025, confirmed that the patient was stable and that no abnormalities were detected on the post-implant ct scan.The implanting physician believes the premature ventricular contractions were caused by potential air bubbles trapped in the sheath or device during preparation.Regarding the hematoma between the aorta and left atrial appendage, the physician was unsure if it was pre-existing, noting that (ice) imaging at the start did not provide clear visuals.No additional information was provided.
Additional Manufacturer Narrative
An event of air was noted in the aorta, arrythmia, and embolism 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 history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Implanting occluder proved challenging due to pectinated and shallow anatomy, with discrepancies between angiography, ice, and pre-procedural ct imaging.The implanting physician believes the premature ventricular contractions were caused by potential air bubbles trapped in the sheath or device during preparation.Based on the information received, the 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 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: 22817060
• Report Number: 2135147-2025-04577
• Device Sequence Number: 15642594
• Product Code: DQY
• UDI-Device Identifier: 05415067025906
• UDI-Public: (01)05415067025906(17)260430(10)9049410
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/12/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: 9-TV45X45-14F-080
• Device Catalogue Number: 9-TV45X45-14F-080
• Device Lot Number: 9049410
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female