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

Model Number	D087031
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This report is to advise of a fracture that was noted during analysis.During the procedure, when inserting the viewflex ice catheter into the heart, it was noted that the catheter went out a branch of the ivc and significantly bent at the tip.After that, the catheter was noted to not steer correctly.It was determined that the steering mechanism was no longer functioning.The catheter was replaced, which resolved the issue, and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One viewflex xtra ice catheter was received for evaluation.A fracture in the catheter tip was noted 0.7¿ proximal to the distal tip.No other visual anomalies were noted.The catheter deflected in all directions and met specifications for curve shape when actuating the steering mechanisms.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.

• 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: 24664323
• Report Number: 2030404-2026-00019
• Device Sequence Number: 15752659
• Product Code: OBJ
• UDI-Device Identifier: 05415067002082
• UDI-Public: (01)05415067002082(10)11044422(17)260924
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 03/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/24/2026
• Device Model Number: D087031
• Device Catalogue Number: D087031
• Device Lot Number: 11044422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2026
• 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: 03/04/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2025
• 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
• Patient Sex: Unknown