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

Model Number	D087031
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During the procedure, the catheter tip detached and was lodged in the sheath.This occurred when inserting the catheter into the 10f sheath.The sheath was removed and exchanged for a new sheath and catheter with no issues.The procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: a3a, a4, a5, d9, g3, h2, h3, h6, h11.One viewflex xtra ice catheter was received for evaluation.The catheter tip was noted to be fractured and detached at the distal tip.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the detached tip remains unknown.

• 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23610360
• Report Number: 3008452825-2025-00585
• Device Sequence Number: 18636469
• Product Code: OBJ
• UDI-Device Identifier: 05415067002082
• UDI-Public: (01)05415067002082(10)11061712(17)260831
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 12/23/2025

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: 08/31/2026
• Device Model Number: D087031
• Device Catalogue Number: D087031
• Device Lot Number: 11061712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2025
• 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: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Hispanic