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

Model Number 2760

Device Problem Inflation Problem (1310)

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

Event Date 08/23/2022

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 05jan2023.It was reported that device was unable to inflate, and no pressure was achieved.An encore 26 advantage kit was selected for use.During the procedure, the indeflator was connected to a balloon catheter and attempted inflation by turning the handle in order to perform dilatation, however, the balloon did not inflate.The meter of the indeflator did not move either; therefore, the handle of the indeflator was turned further, and the meter moved up to 26atm and was able to swing out.The used of the device was discontinued and the procedure was completed with another of the same device.No patient complications reported.However, device investigations revealed that the gauge needle failed to zero.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The gauge needle was at 26 atm when received.The device returned with 5 mil of unknown transparent liquid.For functional testing, the unit passed the pressure damping test (returning to 26 atm).For the vacuum test, there was no bubble leakage.The unit passed the side load test.The gauge accuracy test was not able to de performed due to the needle being at 26 atm without pressure applied.The device locking mechanism test was performed and at the first attempt, the needle returned to 22 atm.At the second attempt, the needle returned to 18 atm.The unit failed the locking mechanism test.The device passed all dimensional tests.The analysis of the returned product confirmed that inflation was unable to be performed since the gauge needle was at 26 atm when received, confirming the reported complaint.

• 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: 16229543
• MDR Text Key: 308010449
• Report Number: 2124215-2023-00908
• 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
• Report Date: 01/23/2023

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 Expiration Date: 04/17/2024
• Device Model Number: 2760
• Device Catalogue Number: 2760
• Device Lot Number: 0029241630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2023
• Initial Date FDA Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2022
• 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