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	04/19/2023
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 a metriq pump was selected for use.During a procedure an error "p07 - pump speed error" occurred.The error was unable to be resolved following replacement of the tubing set.The procedure was cancelled.The pump is expected to be returned for analysis.This event is being reported for aborted/cancelled procedure with a patient under sedation.
Additional Manufacturer Narrative
Section e.Initial reporter was updated with additional information provided.
Event or Problem Description
It was reported that a metriq pump was selected for use.During a procedure an error "p07 - pump speed error" occurred.The error was unable to be resolved following replacement of the tubing set.The procedure was cancelled.The pump is expected to be returned for analysis.This event is being reported for aborted/cancelled procedure with a patient under sedation.
Additional Manufacturer Narrative
Metriq pump was evaluated by boston scientific.After performing functional test, the metriq pump completed and passed all functional testing.After running the pump for an hour and fifty minutes p01 bubble detected error was observed.The metriq pump was restarted multiple times, but the error message was still detected.Troubleshoot by changing the combo bubble sensor with gold unit combo bubble sensor, the device run for two hours and fifteen minutes without any issues.The combo bubble and occlusion will be replaced.A visual inspection of the metriq pump showed no signs of cosmetic damage.Based on the available information, boston scientific investigation findings were unable to establish a clear conclusion about the cause of the reported event even though p01 bubble detected error was observed.The device met all requirements prior to being approved for final distribution sale and there was no evidence to suggest that the instructions for use (ifu) was not followed.
Event or Problem Description
This event is being reported for aborted/cancelled procedure with a patient under sedation.It was reported that a metriq pump was selected for use.During a procedure an error "p07 - pump speed error" occurred.The error was unable to be resolved following replacement of the tubing set.The procedure was cancelled.The pump is expected to be returned for 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16869615
• Report Number: 2124215-2023-21505
• Device Sequence Number: 5385678
• Product Code: OAD
• UDI-Device Identifier: 08714729862123
• UDI-Public: 08714729862123
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup
• Report Date (Section B): 10/18/2023

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: MP5011
• 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: 04/24/2023
• Supplement Date Received by Manufacturer: 05/05/2023; 10/09/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 05/31/2023; 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown