MAUDE Adverse Event Report: ABBOTT MEDICAL VIEWFLEX¿ XTRA ICE CATHETER; Catheter, ultrasound, intravascular

Model Number	D087031
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a pvc procedure, a pericardial effusion occurred which required a pericardiocentesis.Retrograde approach was used and mapping and ablation was performed in the left ventricle outflow tract (lvot).The advisor hd grid mapping catheter was positioned in the right ventricular outflow tract (rvot).The points were earlier there so prior to moving the ablation catheter from the lvot to rvot, the physician performed an ice sweep which revealed a pericardial effusion.A pericardiocentesis was done and 200cc were drained.The physician thinks the viewflex is the likely cause of the effusion because of venous blood as opposed to arterial blood.The patient has since been discharged.There were no performance issues with any abbott device.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.Per the ifu, cardiac tamponade and pericardial effusion are known risks during the use of this device.

• Brand Name: VIEWFLEX¿ XTRA ICE CATHETER
• Common Device Name: Catheter, ultrasound, intravascular
• Manufacturer (Section D): ABBOTT MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ABBOTT MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23550577
• Report Number: 2030404-2025-00057
• Device Sequence Number: 9609219
• Product Code: OBJ
• UDI-Device Identifier: 05415067002082
• UDI-Public: (01)05415067002082(10)10950453(17)260731
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K223077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/13/2025

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: 07/31/2026
• Device Model Number: D087031
• Device Catalogue Number: D087031
• Device Lot Number: 10950453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2025
• 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: Life Threatening; Required Intervention
• Patient Sex: Unknown