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 07/19/2021

Event Type  malfunction  

Event Description

During an atrial fibrillation ablation procedure, the catheter tip was noted to be bent and partially fractured on x-ray following a difficult access through the iliac veins from the groin.The device was replaced and the procedure was completed without any patient consequences.

Manufacturer Narrative

Additional information: d9, g3, h2, h3.One viewflex xtra ice catheter was received for evaluation.Visual inspection revealed a fracture in the catheter tip 0.6¿ proximal to the distal tip.And a bend was noted in the catheter shaft 4.1¿ proximal to the distal tip.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the tip fracture could not be conclusively determined.

• 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
• MDR Report Key: 12220880
• MDR Text Key: 263356803
• Report Number: 3008452825-2021-00394
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 05415067002082
• UDI-Public: 05415067002082
• Combination Product (y/n): N
• PMA/PMN Number: K133853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: D087031
• Device Catalogue Number: D087031
• Device Lot Number: 7875767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 60