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 Consequences Or Impact To Patient (2199)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4) captures the reportable investigation result of gauge reading inaccurate.Investigation result: a visual examination of the returned complaint device revealed that the gauge needle indicated 1 atm.It was noted that the print quality was found clear, legible, and complete.Microscopic inspection was done and found the "y" connector was returned broken in the luer section.Functional evaluation was performed, and the device was not possible to fill due to the "y" connector being broken.Based on the device analysis and the product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, and no abnormalities were reported during the assembly process.It is possible that the factors encountered during the procedure, such as the technique used by the nurse during the test period, could have caused that the luer connection to become broken, causing the leak during the procedure.Also, it is possible that the syringe does not maintain pressure due to the connector being broken during the procedure and that could have caused that the pressure gauge to be returned at 1 atm.Therefore, the most probable root cause is adverse event related to procedure.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 used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noticed that when attempting to inflate the balloon, the luer on the syringe device leaked.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 of the syringe 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: 11162640
• MDR Text Key: 226934304
• Report Number: 3005099803-2020-06741
• 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: Physician
• Type of Report: Initial
• Report Date: 01/13/2021

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: 12/18/2021
• Device Model Number: M00550601
• Device Catalogue Number: 5060-05
• Device Lot Number: 0024956863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2019
• 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