MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LABSYSTEM PRO; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number M00420020340

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem Complete Heart Block (2627)

Event Date 08/14/2018

Event Type  malfunction  

Event Description

It was reported the recording system froze and was the only device in use to monitor heart rhythm.A lab system pro ep recording system and a cryoablation catheter were selected for use during a para-hisian kent ablation procedure.Ablation progress was being monitored by reading endocardial signals.The lab system pro was the only device in use to monitor heart rhythm.The physician was ablating when the screen froze; the screen was no longer transmitting information in real time.During this time, the physician was unable to see changes in rhythm.No error messages popped up.The freeze lasted 10 seconds.The freeze was resolved by pressing the f8 button several times to create a new event.When the signals finally updated, the physician saw atrioventricular (av) block; therefore, he stopped ablating and the av block disappeared.It was unknown how long the av block lasted, as it began when the screen was frozen.The av block was transient and did not require intervention.

• Brand Name: LABSYSTEM PRO
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): EP TECHNOLOGIES, INC.; 150 baytech drive; ,; san jose CA 95134
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 7864907
• MDR Text Key: 119931587
• Report Number: 2134265-2018-60904
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 08714729935872
• UDI-Public: 08714729935872
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00420020340
• Device Catalogue Number: 86623
• Device Lot Number: 0001955176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2016
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1