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	05/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, the catheter was inserted into the patient, but the catheter imaging was unclear.Upon inspection, it was found that the tip was damaged.The catheter was replaced and the procedure was successfully completed with no adverse patient consequences.

• Brand Name: VIEWFLEX¿ XTRA ICE CATHETER
• Common Device Name: Catheter, Ultrasound, Intravascular
• Manufacturer (Section D): ABBOTT MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ABBOTT MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24527367
• Report Number: 3008452825-2026-00115
• Device Sequence Number: 18252644
• Product Code: OBJ
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K223077
• Number of Events Summarized: 1
• Summary Report (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): 09/29/2026

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: 01/31/2026
• Device Model Number: D087031
• Device Catalogue Number: D087031
• Device Lot Number: 10726912
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/04/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2025
• 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