MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE¿ CABLE; CARDIAC CATHETERIZATION MONITORING SYSTEM

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2019

Event Type  Injury  

Event Description

Related manufacturing reference: 2184149-2019-00080.During a procedure, it was not possible to use pressure.The zero baseline was not able to be performed and the pressure curve was not displayed.Additionally, the cable was noted to be damaged and bared, there was noise on the ablation signal and there was intermittent display of the workmate remote screen.Further information revealed the noise issue was resolved by re-organizing the cables, the intermittent display was resolved by re-connecting the dvi cable and the pressure issue was resolved by replacing the damaged cable.The procedure was completed with no patient consequences, however there was a clinically significant delay.

Manufacturer Narrative

Additional information: the results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported pressure, display and noise issues could not be conclusively determined.However, based on troubleshooting the issues were resolved by re-organizing the cables, re-connecting the dvi cable and replacing a damaged cable.Further information regarding the event were requested but not received.

• Brand Name: EP-WORKMATE¿ CABLE
• Type of Device: CARDIAC CATHETERIZATION MONITORING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 8566387
• MDR Text Key: 143604223
• Report Number: 2184149-2019-00081
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K151911
• 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: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 04/30/2019
• Supplement Dates Manufacturer Received: 05/20/2019
• Supplement Dates FDA Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EP-WORKMATE¿ RECORDING SYSTEM WITH CLEARWAVE¿; EP-WORKMATE¿ RECORDING SYSTEM WITH CLEARWAVE¿
• Patient Outcome(s): Other