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

Model Number 2760

Device Problem Material Integrity Problem (2978)

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

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

B3 date of event: estimated based on aware date as event date was not reported.

Event Description

It was reported that a pressure gauge issue occurred.An encore 26 advantage kit was selected for use.During the procedure, after inflation, the atmosphere marker malfunctioned.There were no patient complications reported.

Manufacturer Narrative

B3 date of event: estimated based on aware date as event date was not reported.The device was returned for analysis.A visual inspection was performed; the gauge needle was at 18 atm and it could not be returned to zero.A functional test could not be performed because the device was unable to be returned to zero.

Event Description

It was reported that a pressure gauge issue occurred.An encore 26 advantage kit was selected for use.During the procedure, after inflation, the atmosphere marker malfunctioned.There were no patient complications reported.

• Brand Name: ENCORE 26 ADVANTAGE KIT
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18290452
• MDR Text Key: 330039835
• Report Number: 2124215-2023-69778
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729180005
• UDI-Public: 08714729180005
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K140745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

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: 0032129791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1