MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TORQVUE 2 DS; CATHETER, PERCUTANEOUS

Catalog Number	9-TV2-05F120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994)
Date of Event	01/12/2024
Type of Reportable Event	Serious Injury
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_967 - paradigm, patient site id: (b)(6).It was reported that on (b)(6) 2024, a 10mmx5mm amplatzer valvular plug 3 was successfully implanted in a patient using a 5f amplatzer torqvue 2 delivery sheath.On (b)(6) 2024, it was noted that the patent went to the emergency room due to testicular pain.The patient was found to have orchitis and a scrotal hematoma.It believe that the cause was from venous access during the implant procedure.
Additional Manufacturer Narrative
An event of hematoma and pain was reported.A returned device assessment could not be performed as the device was not returned for analysis.Information from the field indicated that the patient went to the emergency room due to testicular pain from orchitis.The patient presented with orchitis due to a scrotal hematoma.Based on the information received, the cause of the reported pain was due to orchitis.However, the cause of the reported hematoma could not be determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
Clinical information:(b)(6)- paradigm, patient site id: (b)(6)((b)(6)) it was reported that on (b)(6)2024, a 10mm x 5mm amplatzer valvular plug 3 was successfully implanted in a patient using a 5f amplatzer torqvue 2 delivery sheath.There was no difficulty implanting the plug.There were no multiple manipulations of the delivery sheath during the procedure.On(b)(6)2024, it was noted that the patent went to the emergency room due to testicular pain.The patient presented with orchitis due to a scrotal hematoma.It could not be confirmed by the implanting physician if the cause of the scrotal hematoma was or was not from the delivery system's venous access from the implant procedure.The patient status was reported as discharged.

• Brand Name: AMPLATZER TORQVUE 2 DS
• 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: 18743890
• Report Number: 2135147-2024-00773
• Device Sequence Number: 17952730
• Product Code: DQY
• UDI-Device Identifier: 00811806012476
• UDI-Public: 00811806012476
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K162228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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 Catalogue Number: 9-TV2-05F120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 102 KG