MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION METRIQ PUMP; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number 86337

Device Problem Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2019

Event Type  malfunction  

Manufacturer Narrative

The device was received fair condition with no visible damage observed.The unit failed at step 1.5 of the metriq pump functional test.The unit displays "open door fully and re close before continuing".

Event Description

It was reported that the procedure was aborted due to a device malfunction.It was reported that the meritq pump is turning on and off suddenly.The procedure was abandoned.There were no patient complications reported.

• Brand Name: METRIQ PUMP
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): FREMONT FACILITY; 47215 lakeview blvd; fremont CA 94538 6530
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 9315110
• MDR Text Key: 173449290
• Report Number: 2134265-2019-13778
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729862123
• UDI-Public: 08714729862123
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P150005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 86337
• Device Catalogue Number: 86337
• Device Lot Number: MP0132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2018
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1