MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CLEARSIGN AMPLIFIER FOR LABSYSTEM PRO EP RECORDING SYSTEM; AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL

Model Number 86620

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2020

Event Type  malfunction  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that a clearsign amplifier for labsystem pro ep recording system was selected for a procedure.During the procedure it was noted that there was signal noise.The procedure was canceled due to this noise.No patient complications were reported.

• Brand Name: CLEARSIGN AMPLIFIER FOR LABSYSTEM PRO EP RECORDING SYSTEM
• Type of Device: AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): CREATION TECHNOLOGIES INCORPORATED; 8999 fraserton court; burnaby bc V5J 5 H8; CA V5J 5H8
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 10250605
• MDR Text Key: 198126953
• Report Number: 2134265-2020-09114
• Device Sequence Number: 1
• Product Code: DRQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/09/2020

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 Model Number: 86620
• Device Catalogue Number: 86620
• Device Lot Number: 1A485217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 07/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2015
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1