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

Model Number D087031

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

Related manufacturing ref: 2030404-2020-00109.During an atrial fibrillation ablation procedure, the distal end of the catheter became caught during insertion.It seemed to be caught in the iliac or vertebral body.When attempting to advance past that point, the tip snapped at a 45-degree angle.The catheter was replaced, and the procedure was successfully completed with no clinically significant delay, or adverse consequences for the patient.

Manufacturer Narrative

Additional information: d9, g3, h2, h3.One viewflex xtra ice catheter was received for evaluation.The catheter tip was noted to be bent and fractured; however, the investigation could not be concluded and could not be determined when and how the catheter tip was fractured and remained unknown.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• 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
• MDR Report Key: 11059401
• MDR Text Key: 231616575
• Report Number: 2030404-2020-00110
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: D087031
• Device Catalogue Number: D087031
• Device Lot Number: 7679121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VIEWFLEX¿ XTRA ICE CATHETER