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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 07/01/2022

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 15-sep-2022.The encore balloon catheter inflation device was returned with no reported allegations.However, device analysis revealed that the gauge needle was lost between 26 atm and 0 atm.

Manufacturer Narrative

Device evaluated by manufacturer: the encore ic was returned for analysis.A visual inspection was conducted, and the encore ic did not have any visual defects.The gauge needle was at 0 atm when received.A pressure damping test was conducted, the pressure did not increase beyond 4 atms and a significant leakage was observed under the cage (near the gauge).A vacuum test was conducted, the vacuum was created, however, a leakage was observed in the barrel.The encore ic passed side load testing.The encore ic device locking mechanism test was performed, at first attempt the pressure only achieve 4 atms.Additional attempts were not completed as a significant leakage was observed under the cage (near the gauge).The device was then disassembled, and the following functional testing was performed.The encore ic passed the pressure damping test.A vacuum test was conducted, there was no bubble leakage observed.The encore ic passed side load testing.The device locking mechanism test was performed, it was found the needle of the gauge was lost between 26 atm and 0 atm at the second attempt.After dissembled, contrast media residue was found in the o ring of the gauge.

• Brand Name: ENCORE BALLOON CATHETER INFLATION DEVICE
• 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: 15552359
• MDR Text Key: 301273355
• Report Number: 2134265-2022-08885
• Device Sequence Number: 1
• Product Code: MAV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2022
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/06/2022
• 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