MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENCORE 26 ADVANTAGE KIT; SYRINGE, BALLOON INFLATION

Model Number 2760

Device Problems Display or Visual Feedback Problem (1184); Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2022

Event Type  malfunction  

Event Description

It was reported that the gauge needle did not show the proper pressure.An encore 26 advantage kit was selected for use.During the procedure, it was noted that the gauge needle did not show the proper pressure.Subsequently, the gauge moved up to 26 atmospheres when the handle of the indeflator was turned and it was shaken out.The procedure was completed with another of the same device.No complications were reported, and the patient was in good condition after the procedure.

Manufacturer Narrative

Device evaluated by manufacturer: unit returned and overall visual revision did not identify failures or evidence that could be lost due to decontamination process.Visual inspection was performed and the gauge needle was between 0 atm and 26 atm when received.Functional testing was performed.During preparation, plunger feels hard to activate.Pressure damping test is to ensure the unit falls from 13 atm to 0 atm within 1 second.The unit passed the test.Assuming between 0 atm and 26 atm its the zero position, pressure its increased onto 8 atm and returns to the tentative 0.Vacuum test.The unit was primed with 5 ml of water before withdrawing the plunger to create a vacuum.Not able to complete since pressure was not able to increase more than 8 atm and there is not accurate position to identify the vacuum (considering that between 0 atm and 26 atm was the zero position) side load test was performed and the unit pass if the unit maintains a vacuum in this position.The unit passes the test.Gauge accuracy test at 13 atm, 26 atm & 0 atm to assess the accuracy of the gauge under pressurization.Test not able to be performed since the issue with the needle.The device locking mechanism test was performed.This is where the plunger handle is rotated to achieve 26 atm and this test is repeated 20 times consecutively.Test not able to be performed since state of the needle.Dimensional testing passed measurements.

Event Description

It was reported that the gauge needle did not show the proper pressure.An encore 26 advantage kit was selected for use.During the procedure, it was noted that the gauge needle did not show the proper pressure.Subsequently, the gauge moved up to 26 atmospheres when the handle of the indeflator was turned and it was shaken out.The procedure was completed with another of the same device.No complications were reported, and the patient was in good condition after the procedure.

Manufacturer Narrative

Correction as it was initially reported that the h6 conclusion code was "conclusion not yet available" updated h6 conclusion code to "cause not established." device evaluated by manufacturer: unit returned and overall visual revision did not identify failures or evidence that could be lost due to decontamination process.Visual inspection was performed and the gauge needle was between 0 atm and 26 atm when received.Functional testing was performed.During preparation, plunger feels hard to activate.Pressure damping test is to ensure the unit falls from 13 atm to 0 atm within 1 second.The unit passed the test.Assuming between 0 atm and 26 atm its the zero position, pressure its increased onto 8 atm and returns to the tentative 0.Vacuum test.The unit was primed with 5 ml of water before withdrawing the plunger to create a vacuum.Not able to complete since pressure was not able to increase more than 8 atm and there is not accurate position to identify the vacuum (considering that between 0 atm and 26 atm was the zero position) side load test was performed and the unit pass if the unit maintains a vacuum in this position.The unit passes the test.Gauge accuracy test at 13 atm, 26 atm & 0 atm to assess the accuracy of the gauge under pressurization.Test not able to be performed since the issue with the needle.The device locking mechanism test was performed.This is where the plunger handle is rotated to achieve 26 atm and this test is repeated 20 times consecutively.Test not able to be performed since state of the needle.Dimensional testing passed measurements.

Event Description

It was reported that the gauge needle did not show the proper pressure.An encore 26 advantage kit was selected for use.During the procedure, it was noted that the gauge needle did not show the proper pressure.Subsequently, the gauge moved up to 26 atmospheres when the handle of the indeflator was turned and it was shaken out.The procedure was completed with another of the same device.No complications were reported, and the patient was in good condition after the procedure.

• Brand Name: ENCORE 26 ADVANTAGE KIT
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15438830
• MDR Text Key: 303917818
• Report Number: 2124215-2022-36160
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729180005
• UDI-Public: 08714729180005
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K140745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2023

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
• Device Operator: Health Professional
• Device Model Number: 2760
• Device Catalogue Number: 2760
• Device Lot Number: 0029705633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/16/2022
• Supplement Dates Manufacturer Received: 11/24/2022; 01/13/2023
• Supplement Dates FDA Received: 12/05/2022; 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1