MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	GUIDEWIRE
Medical Device Problem Codes	Difficult to Remove (1528); Use of Device Problem (1670); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Hypoxia (1918); Perforation of Vessels (2135)
Date of Event	01/10/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2023, an unknown mitraclip was chosen for implant using an amplatzer guidewire.Difficulty was encountered when attempting to remove the super stiff guidewire, which was anchored in the left superior pulmonary vein.After a few attempts, the guidewire was removed into the mitraclip steerable guide catheter.Minutes later, the patient presented significant bleeding through the orotracheal tube with a drop in oxygen saturation.The reversal of heparin with protamine was performed, and the orotracheal tube was changed twice, as it was obstructed by clots.The bleeding gradually stabilized, and the patient regained oxygen saturation.The mitraclip procedure was aborted.The patient was reported as stable and on mechanical ventilation in the intensive care unit.On an unknown date, the patient died.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Date of death - is estimated as (b)(6) 2023 as that was the date the death was reported to abbott.
Additional Manufacturer Narrative
An event of difficulty while attempting to remove a guidewire anchored in the left superior pulmonary vein and patient death was reported.A returned device assessment could not be performed as the device was not returned for analysis.However, one image was received from the field appearing to show the label of the device involved in the reported event.Information from the field indicated that there was difficulty removing the guidewire anchored in the left superior pulmonary vein and it was thought the guidewire perforated the vessel.Information from the field indicated that the patient's death was unrelated to device performance.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.H6: medical device problem code: code 4001 removed.
Event or Problem Description
Subsequent to the initially filed report, the following information was received that the patient's cause of death was cardiogenic shock, respiratory failure, multiorgan dysfunction syndrome.

• Brand Name: AMPLATZER GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16303340
• Report Number: 2135147-2023-00394
• Device Sequence Number: 14996286
• Product Code: DQX
• UDI-Device Identifier: 00811806010724
• UDI-Public: 00811806010724
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K053187
• 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): 05/05/2023

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 Model Number: GUIDEWIRE
• Device Catalogue Number: 9-GW-002
• Device Lot Number: 9941803
• 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: 01/10/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2022
• 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: Death
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 54 KG