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

Model Number	9-ITV07F180/80
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	03/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event of an inverted sheath tip was confirmed.Gross morphological examination revealed the sheath tip was inverted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined.
Event or Problem Description
This event is being conservatively reported for the patient's hemodynamic changes that occurred during implantation of the occluder.On (b)(6) 2021, a 10/12 patent ductus arteriosus (pda) device was selected for procedure.The device was used with the 7fr delivery system.During device preparation, the sheath was fine.When the device was positioned on the pda for closure, the hemodynamics of the patient changed and the patient became unstable on retrieval while the user tried to reposition the device, the device would not pull into the 7fr sheath.The effort was attempted 4 to 5 times with lots of resistance at the tip of the sheath.The 7fr delivery sheath was then exchanged for a bigger sheath, a 8fr.The user reports the tip of the sheath was deformed reporting the tip of the sheath (light blue part) appeared inverted and concluded it was the reason for the resistance.The device did pull into the 8 fr delivery sheath however the 8fr sheaths tip also became deformed.While retrieving the device, the patient remained stable.

• Brand Name: AMPLATZER TORQVUE DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11886728
• Report Number: 2135147-2021-00187
• Device Sequence Number: 11670897
• Product Code: DQY
• UDI-Device Identifier: 00811806010793
• UDI-Public: 00811806010793
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 9-ITV07F180/80
• Device Catalogue Number: 9-ITV07F180/80
• Device Lot Number: 7756374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention