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

Model Number 3040

Device Problems Break (1069); Display or Visual Feedback Problem (1184)

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

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

B3.Used first day of the aware date as the event date was not reported.

Event Description

It was reported that the gauge was showing incorrect pressure.An encore 26 inflation device was selected for use.The encore device inflated the balloon even though the pressure gauge needle did not move.Additionally, a loose jingling sound was heard when the indeflator was moved which may indicate that there is a broken part within.The procedure was completed with another of the same device.There were no patient complications reported.

Event Description

It was reported that the gauge was showing incorrect pressure.An encore 26 inflation device was selected for use.The encore device inflated the balloon even though the pressure gauge needle did not move.Additionally, a loose jingling sound was heard when the indeflator was moved which may indicate that there is a broken part within.The procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

B3.Used first day of the aware date as the event date was not reported.Device evaluated by manufacturer: the device was returned for analysis.A visual and functional analysis were performed on the device.The gauge needle was at 0 atm when received.The device does not have visual defects.The unit passed all functional tests without issues.

• Brand Name: ENCORE 26
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; 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: 18389169
• MDR Text Key: 331377587
• Report Number: 2124215-2023-69753
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729177029
• UDI-Public: 08714729177029
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K955869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

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: 3040
• Device Catalogue Number: 3040
• Device Lot Number: 0031913176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2023
• 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