MAUDE Adverse Event Report: ABBOTT MEDICAL VIEWFLEX¿ XTRA ICE CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	D087031
Medical Device Problem Codes	Fracture (1260); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One viewflex xtra ice catheter was received for evaluation.The catheter was noted to be bent and fractured 0.60¿ proximal to the distal tip.The catheter was recognized by the catheter interface module and viewmate system and the imaging screen was displayed; visual abnormalities were noted, the dot pattern appeared stretched, consistent with the fractured tip.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the observed bent catheter tip remains unknown.
Event or Problem Description
This report is to advise of a fracture found in the catheter tip during analysis.
Additional Manufacturer Narrative
Additional information: b5, g3, h2, h3, h6, h11.One viewflex xtra ice catheter was received for evaluation.The catheter was noted to be bent and fractured 0.60¿ proximal to the distal tip.The catheter was recognized by the catheter interface module and viewmate system and the imaging screen was displayed; visual abnormalities were noted, the dot pattern appeared stretched, consistent with the fractured tip.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The viewflex xtra ice catheter instructions for use (ifu) states, ¿use a 10f or larger introducer sheath.¿ the cause of the observed fractured catheter tip remains unknown.
Event or Problem Description
During the af procedure, when the viewflex catheter was inserted, the image displayed noise, appearing as a black line.The catheter was replaced, and the procedure was completed with no adverse consequences to the patient.A 9f sheath was used when a 10f should.

• 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23689790
• Report Number: 2030404-2025-00065
• Device Sequence Number: 21380585
• Product Code: OBJ
• UDI-Device Identifier: 05415067002082
• UDI-Public: (01)05415067002082(10)10774108(17)260404
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2025

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: 04/04/2026
• Device Model Number: D087031
• Device Catalogue Number: D087031
• Device Lot Number: 10774108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2025
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2025
• 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