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

Model Number D087031

Device Problem Material Separation (1562)

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

Event Date 12/28/2020

Event Type  malfunction  

Manufacturer Narrative

The results, method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During the procedure, there was difficulty obtaining an image with the device.After several attempts to reposition the device, the catheter was removed and it was noticed that the transducer tip was separating from the body of the catheter.

Manufacturer Narrative

Additional information: d9, g3, g6, h2, h3, h6.One viewflex xtra ice catheter was received for complaint evaluation.It was confirmed that the distal tip of the catheter was kinked and fractured.However, the catheter was in one piece.The catheter tip dissection was verified the presence of the components, no anomaly was noted; even with the damage on the tip section.The device history record was reviewed to ensure that each manufacturing and inspection operations was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the investigation performed and the information provided, the cause of the reported fracture remains unknown.

• Brand Name: VIEWFLEX XTRA ICE CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• MDR Report Key: 11230107
• MDR Text Key: 228682437
• Report Number: 2030404-2020-00111
• 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

• 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: 7697853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 04/09/2021
• Supplement Dates FDA Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1