MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TORQVUE DELIVERY SYSTEM; CATHETER, PERCUTANEOUS

Catalog Number	9-ITV09F45/80
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Hematoma (1884)
Date of Event	05/15/2020
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
It was reported that on (b)(6) 2020, 25mm amplatzer pfo occluder was chosen for implant using a 9f amplatzer torqvue delivery system.During procedure, the device was removed due to mis-sizing.The device never released from the cable.A new 35mm amplatzer pfo occluder was chosen and successfully implanted.On (b)(6) 2020, prior to discharge, anemia and hematoma at groin was confirmed, manual compression was conducted.On (b)(6) 2020, blood transfusion was conducted.The issue was resolved without sequelae on (b)(6), 2020.The physician mentioned the issue was possibly related to the implant procedure.On (b)(6) 2020, the patient was reported discharged from the hospital without sequelae.The patient was reported stable.
Event or Problem Description
It was reported that on (b)(6) 2020, 25mm amplatzer pfo occluder was chosen for implant using a 9f amplatzer torqvue delivery system.During procedure, the device was removed due to mis-sizing.The device never released from the cable.A new 35mm amplatzer pfo occluder was chosen and successfully implanted.On (b)(6) 2020, prior to discharge, anemia and hematoma at groin was confirmed, manual compression was conducted.On (b)(6) 2020, blood transfusion was conducted.The issue was resolved without sequelae on (b)(6) 2020.The physician mentioned the issue was possibly related to the implant procedure.On (b)(6) 2020, the patient was reported discharged from the hospital without sequelae.The patient was reported stable.
Additional Manufacturer Narrative
An event of anemia and hematoma was reported.During procedure, a 25 mm pfo device was removed due to mis-sizing and a 35 mm device was implanted.It was also reported that manual compression and blood transfusion were conducted and the event was resolved without sequelae.The patient was reported as stable.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER TORQVUE DELIVERY SYSTEM
• 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: 19055551
• Report Number: 2135147-2024-01567
• Device Sequence Number: 8120984
• Product Code: DQY
• UDI-Device Identifier: 00811806010861
• UDI-Public: (01)00811806010861(17)220831(10)7188469
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072313
• 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): 05/09/2024

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: 08/31/2022
• Device Catalogue Number: 9-ITV09F45/80
• Device Lot Number: 7188469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2019
• 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; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 45 KG