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

Model Number	86337
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the metriq pump enter key was not functional.During a procedure a metriq pump, hospital owned was selected for use.After the pump was started the "enter" key could not be pressed.The pump was started up and connected again, but the same issue occurred.After pressing the key about 50 times it was miraculously able to enter.The procedure was cancelled.No patient complications were reported.
Additional Manufacturer Narrative
Correction: impact code updeted from f26: no health consequences or impact to f1001: absence for treatment.It was further reported that the high flow minus button did not respond during an attempted field repair.The pump will be returned for repair.
Event or Problem Description
It was reported that the metriq pump enter key was not functional.During a procedure a metriq pump, hospital owned was selected for use.After the pump was started the "enter" key could not be pressed.The pump was started up and connected again, but the same issue occurred.After pressing the key about 50 times it was miraculously able to enter.The procedure was cancelled.No patient complications were reported.This event is being reported for aborted/cancelled procedure with a patient under sedation.
Event or Problem Description
It was reported that the metriq pump enter key was not functional.During a procedure a metriq pump, hospital owned was selected for use.After the pump was started the "enter" key could not be pressed.The pump was started up and connected again, but the same issue occurred.After pressing the key about 50 times it was miraculously able to enter.The procedure was cancelled.No patient complications were reported.This event is being reported for aborted/cancelled procedure with a patient under sedation.
Additional Manufacturer Narrative
It was further reported that the high flow minus button did not respond during an attempted field repair.Upon receipt at our post market quality assurance laboratory the metriq pump underwent visual inspection and functional testing.It was confirmed that while conducting the cis metriq functional test the enter button did not work as intended.Troubleshooting was done by replacing the keypad assembly with a gold unit keypad.The metriq pump completed and passed functional testing, and the keypad assembly will be replaced.Additionally, a visual inspection of the metriq pump showed that the door assembly did not close smoothly as intended and will be replaced.Laboratory analysis confirmed the reported clinical observations.

• Brand Name: METRIQ PUMP
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16497720
• Report Number: 2124215-2023-09588
• Device Sequence Number: 20445980
• Product Code: OAD
• UDI-Device Identifier: 08714729862116
• UDI-Public: 08714729862116
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P150005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2023

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
• Operator of Device: Health Professional
• Device Model Number: 86337
• Device Catalogue Number: 86337
• Device Lot Number: MP1023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 05/12/2023; 07/17/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 06/07/2023; 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown