MAUDE Adverse Event Report: ST. JUDE MEDICAL VIEWFLEX¿ XTRA ICE CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number D087031

Device Problems Fracture (1260); Difficult to Insert (1316)

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

Event Date 08/24/2022

Event Type  malfunction  

Event Description

During a persistent atrial fibrillation procedure, resistance was noted during insertion into the sheath and a fracture occurred approximately 1.5 cm from the tip.Another catheter was used to complete the procedure with no adverse consequences to the patient.

Manufacturer Narrative

One viewflex xtra ice catheter was received for evaluation.The catheter tip was noted to be bent and fractured.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The root cause of this issue was determined to be a design/process issue.

• Brand Name: VIEWFLEX¿ XTRA ICE CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): ST. JUDE 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): ST. JUDE 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15296655
• MDR Text Key: 305348494
• Report Number: 3008452825-2022-00570
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 05415067002082
• UDI-Public: 05415067002082
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: D087031
• Device Catalogue Number: D087031
• Device Lot Number: 8294873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1