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

Model Number M00550601

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

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation result: a visual examination of the returned complaint device revealed that the gauge needle indicated 5 atm.It was noted that the print quality was found clear, legible, and complete.Also, the "y" connector was returned straight and aligned with the syringe.Microscopic inspection was done and found the thread of the female luer had no damages.As there was no issue with the visual and functional test during product analysis, the complaint incident cannot be confirmed.Regarding the gauge issue, it is possible the balloon burst during the procedure and the gauge resultingly was unable to zero itself, resulting in the found gauge issue.However, regarding the reported event of the luer breaking, taking into consideration the evaluation conducted and the details of the complaint, the most probable root cause of the reported event cannot be detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.

Event Description

It was reported to boston scientific corporation that an alliance inflation syringe was unpacked to be used for a dilation procedure performed in the esophagus on an unknown date.It was noticed that the luer lock was broken upon opening package.The procedure was completed with another alliance inflation syringe.There were no patient complications reported as a result of this event.Investigation results revealed that the gauge was reading inaccurately; therefore, this is now an mdr reportable event.

• 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: 11734037
• MDR Text Key: 248275238
• Report Number: 3005099803-2021-01869
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729129332
• UDI-Public: 08714729129332
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2021

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: 10/21/2022
• Device Model Number: M00550601
• Device Catalogue Number: 5060-05
• Device Lot Number: 0026223196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2020
• 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