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

Model Number 2760

Device Problems Deflation Problem (1149); Material Integrity Problem (2978)

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

Event Date 04/26/2022

Event Type  malfunction  

Event Description

It was reported that failure to deflate occurred.An encore 26 advantage kit inflation device was selected for use.During the procedure, upon deflation of balloon, it was noted that the pressure gauge stayed at maximum inflation pressure.The balloon was successfully deflated using another deflation device.The procedure was completed with another of same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the encore ic was returned for analysis.A visual inspection was conducted, and the encore ic did not have any visual defects.The gauge needed was at 26 atm when received.Functional inspection was conducted, the needle can move when increasing air pressure using the plunger and when releasing it gets back to 18 atm.A pressure damping test was conducted and the encore ic passed the test.A vacuum test was conducted, there was no bubble leakage observed.The encore ic passed side load testing.The encore ic gauge accuracy test was not able to be completed due to the loss of the needle zero location.

Event Description

It was reported that failure to deflate occurred.An encore 26 advantage kit inflation device was selected for use.During the procedure, upon deflation of balloon, it was noted that the pressure gauge stayed at maximum inflation pressure.The balloon was successfully deflated using another deflation device.The procedure was completed with another of same device.No patient complications were reported.

• 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: 14291368
• MDR Text Key: 290919836
• Report Number: 2134265-2022-05221
• Device Sequence Number: 1
• Product Code: MAV
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

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
• Device Operator: Health Professional
• Device Model Number: 2760
• Device Catalogue Number: 2760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 04/26/2022
• Initial Date FDA Received: 05/05/2022
• Supplement Dates Manufacturer Received: 09/14/2022
• Supplement Dates FDA Received: 10/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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