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

Model Number	86337
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device.If there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported, that during a procedure to treat a ventricular tachycardia (vt).A metriq pump and an intellanav stablepoint catheter were selected for use.Had several error messages, and they appeared multiple times from the metriq pump.Temperature drop, communication and occlusion.Some of the troubleshooting steps taken include, pushing on the alarm buttons, turning pump and maestro off/on, opening the pump door and re-calibrate.Taking out the catheter and flush with high speed/turn on low drip rate and then reintroduce.Had to do it several times because the errors reappeared after some time.Only the occlusion error could not be resolved.The physician did not want to use a new catheter to resolve the issue.The procedure was already taking a long time, so it was cancelled.Patient was sedated with general anesthesia.The pump is expected to be returned, following receipt of a replacement unit.This event is being reported for aborted/cancelled procedure with a patient under sedation.
Additional Manufacturer Narrative
Metriq pump was evaluated by boston scientific.The combo bubble and occlusion sensor failed, and a visual inspection of the metriq pump showed signs of cosmetic damage on rear enclosure and loose door lock on the door assembly.Laboratory analysis was able to confirm the reported clinical observations.The cause of the issue was traced to component failure as the bubble and occlusion sensor failed, which caused the repeated and unreconcilable error messages.
Event or Problem Description
This event is being reported for aborted/cancelled procedure with a patient under sedation.It was reported that during a procedure to treat a ventricular tachycardia (vt), a metriq pump and an intellanav stablepoint catheter were selected for use.Had several error messages and they appeared multiple times from the metriq pump: temperature drop, communication and occlusion.Some of the troubleshooting steps taken include pushing on the alarm buttons, turning pump and maestro off/on, opening the pump door and re-calibrate.Taking out the catheter and flush with high speed/turn on low drip rate and then reintroduce.Had to do it several times because the errors reappeared after some time.Only the occlusion error could not be resolved.The physician did not want to use a new catheter to resolve the issue.The procedure was already taking a long time so it was cancelled.Patient was sedated with general anesthesia.The pump was returned to boston scientific for laboratory analysis.

• 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: 17203986
• Report Number: 2124215-2023-32228
• Device Sequence Number: 6592030
• Product Code: OAD
• UDI-Device Identifier: 08714729862123
• UDI-Public: 08714729862123
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023

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: MP0115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown