MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. VIEWMATE¿ Z CATHETER INTERFACE MODULE; SYSTEM, SIGNAL ISOLATION

Model Number H701374

Device Problems Display or Visual Feedback Problem (1184); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a cryo atrial fibrillation procedure, a rattling noise was heard within the cim and the unit displayed dark images so the procedure was cancelled.There were no adverse consequences to the patient due to the cancellation.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The cim was replaced in the field and the customer retained the unit so it will not be returned.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported display issue and subsequent procedure cancellation could not be conclusively determined.

• Brand Name: VIEWMATE¿ Z CATHETER INTERFACE MODULE
• Type of Device: SYSTEM, SIGNAL ISOLATION
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 9530630
• MDR Text Key: 173170087
• Report Number: 2184149-2019-00257
• Device Sequence Number: 1
• Product Code: DRJ
• UDI-Device Identifier: 05415067013743
• UDI-Public: 05415067013743
• Combination Product (y/n): N
• PMA/PMN Number: K151175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H701374
• Device Catalogue Number: H701374
• Device Lot Number: 5074241
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other