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

Model Number	3040
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 11oct2022.It was reported that the device could not inflate.An encore 26 inflation device was selected for use.During preparation, when connecting the device to the balloon, an inflation issue was noted.There was a leak observed in the hub luer area.The device was replaced with another of same device.No complications were reported.However, device analysis revealed that the needle failed to zero between 0 atm and 26 atm.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed.The gauge needle was at 0 atm when received.The device does not have visual defects.The luer connector was inspected and no damages were noted.No damages were noted in the returned device.Functional test was performed.A functional test of the complaint device was carried out using a bsc stopcock.The purpose is to ensure that the unit meets the required specification.The pressure damping test is to ensure the unit falls from 13 atm to 0 atm within 1 second.The unit passed the test.The vacuum test was performed.The unit was primed with 5 ml of water before withdrawing the plunger to create a vacuum.There was no bubble leakage.The side load test involved applying a load of 3.5 +/- 0.1 kg to the proximal end of the handle.The unit pass if the unit maintains a vacuum in this position.The unit passes the test.The gauge accuracy test at 13 atm, 26 atm & 0 atm to assess the accuracy of the gauge under pressurization.Results passed the test.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.However, in the cycle number 4 the device was not return to zero, the needle failed to zero between 0 atm and 26 atm.

• Brand Name: ENCORE 26
• Common Device Name: 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: 15660578
• Report Number: 2124215-2022-41750
• Device Sequence Number: 17571885
• Product Code: MAV
• UDI-Device Identifier: 08714729177029
• UDI-Public: 08714729177029
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K955869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2022

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 Expiration Date: 06/19/2024
• Device Model Number: 3040
• Device Catalogue Number: 3040
• Device Lot Number: 0029620746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown