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

Catalog Number	9-TV45X45-12F-080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical information: (b)(6) - amulet china pms, patient site id: (b)(6).It was reported that on (b)(6) 2024, a 22mm amplatzer amulet left atrial appendage occluder was implanted in a patient using a 12f amplatzer torqvue 45x45 delivery sheath.An atrial fibrillation ablation was a concomitant procedure.On (b)(6) 2024, the patient had chest pain for one day, which worsened for 10 hours.The patient went to an outpatient department to complete relevant examinations and then went to the emergency department.The patient was hospitalized due to pericarditis.The physician considered that use of anticoagulation medication caused the pericarditis after the procedure.The subcutaneous bruising at the puncture site and pain symptoms were alleviated after anticoagulation medication was discontinued during the hospitalization.The patient was stable.
Additional Manufacturer Narrative
An event of patient effects pain 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 defined manufacturing specifications.The investigation determines the cause for the reported pain could not be conclusively determined.The reported unexpected medical intervention was the results of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Clinical information: crd_1028 - amulet china pms, patient site id: (b)(6).It was reported that on (b)(6) 2024, a 22mm amplatzer amulet left atrial appendage occluder was implanted in a patient using a 12f amplatzer torqvue 45x45 delivery sheath.An atrial fibrillation ablation was a concomitant procedure.On (b)(6) 2024, the patient had chest pain for one day, which worsened for 10 hours.The patient went to an outpatient department to complete relevant examinations and then went to the emergency department.The patient was hospitalized due to pericarditis.The physician considered that use of anticoagulation medication caused the pericarditis after the procedure.The subcutaneous bruising at the puncture site and pain symptoms were alleviated after anticoagulation medication was discontinued during the hospitalization.The patient was 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: 20317046
• Report Number: 2135147-2024-04752
• Device Sequence Number: 15370939
• Product Code: DQY
• UDI-Device Identifier: 05415067025883
• UDI-Public: (01)05415067025883(17)251031(10)8742360
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: 9-TV45X45-12F-080
• Device Lot Number: 8742360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2022
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 65 KG