MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC VIEWFLEX¿ XTRA ICE CATHETER; Catheter, ultrasound, intravascular

Model Number D087031

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2023

Event Type  malfunction  

Manufacturer Narrative

One viewflex xtra ice catheter was received for evaluation.The catheter tip was noted to be bent and fractured.Due to the aforementioned damage to the catheter tip, functional testing could not be performed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The root cause of the fractured tip was determined to be a design/process issue.

Event Description

This report is to advise of a tip fracture noted during analysis.

• Brand Name: VIEWFLEX¿ XTRA ICE CATHETER
• Type of Device: Catheter, ultrasound, intravascular
• Manufacturer (Section D): ST. JUDE MEDICAL, INC; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18668082
• MDR Text Key: 334902541
• Report Number: 2030404-2024-00012
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2024

1 Device was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D087031
• Device Lot Number: 9190981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No