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	02/03/2026
Type of Reportable Event	Malfunction
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 batch record was reviewed to ensure that each manufacturing and inspection operation was performed.
Event or Problem Description
During a pfa procedure using a non-abbott sheath (faradrive by boston scientific), when preparing to do the transeptal puncture, the viewflex catheter was inserted through the femoral access.Resistance was noted when reaching the external iliac.The catheter was removed from the patient, and a fractured tip was observed.The catheter was replaced, and the procedure was completed with no adverse consequences to the patient.

• 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: 24489308
• Report Number: 3008452825-2026-00099
• Device Sequence Number: 5104674
• Product Code: OBJ
• UDI-Device Identifier: 05415067002082
• UDI-Public: (01)05415067002082(10)11145058(17)261031
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 03/02/2026

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 Model Number: D087031
• Device Catalogue Number: D087031
• Device Lot Number: 11145058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2026
• 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: 02/03/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2025
• 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