MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALLIANCE II; SYRINGE, BALLOON INFLATION

Model Number M00550601

Device Problems Display or Visual Feedback Problem (1184); Leak/Splash (1354)

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

Event Date 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: approximated based on the date the manufacturer became aware of the event.(b)(4).

Event Description

It was reported to boston scientific corporation that an alliance inflation syringe was used in the esophagus during an esophageal stricture dilation procedure performed on an unknown date.During procedure, it was noticed that the gauge needle would not move when pressure was being applied with the syringe.The procedure was completed with another alliance inflation syringe.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that an alliance inflation syringe was used in the esophagus during an esophageal stricture dilation procedure performed on an unknown date.During procedure, it was noticed that the gauge needle would not move when pressure was being applied with the syringe.The procedure was completed with another alliance inflation syringe.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: device problem code a0902 captures the reportable event of gauge reading inaccurate.Block h10: investigation results.The returned alliance inflation syringe was analyzed, and a visual evaluation found that there were no damages to the syringe but, the extension tube was blocked.Microscopic inspection confirmed the device was blocked.A functional inspection was performed and the syringe was inflated with water.However, the device did not fill with water due to a blockage in the extension tube on the female side.The device was filled with water without the extension tube and the syringe was pressurized to 10 atm for 30 seconds.The pressure reading on the gauge was accurate and no leaks were found.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of gauge reading inaccurately was not confirmed.No damages were found on the returned device and the pressure reading was accurate during functional testing without the extension tube.However, a blockage was found in the extension tube of the alliance syringe.This is likely to have occurred due to factors encountered during the manufacturing of the device.Therefore, the most probable root cause is manufacturing deficiency.An investigation to address this problem has been completed.

• Brand Name: ALLIANCE II
• 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; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16070988
• MDR Text Key: 308540237
• Report Number: 3005099803-2022-07776
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729129332
• UDI-Public: 08714729129332
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K922573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

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: 02/21/2024
• Device Model Number: M00550601
• Device Catalogue Number: 5060-05
• Device Lot Number: 0028907363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 02/14/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2022
• 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