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

Model Number M00550600

Device Problems Display or Visual Feedback Problem (1184); Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)

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

Event Date 05/01/2023

Event Type  malfunction  

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0902 captures the reportable event of reading inaccurate.Block h10: investigation results: the returned alliance inflation syringe was analyzed, and a visual examination found that the needle's gauge returned at 10 atm.The print quality was inspected, and it was found clear, legible and complete.The y connector was returned straight and aligned with the syringe.A functional inspection was performed, and the syringe was connected to an alliance inflation system.The syringe was filled with water and no problems were noted, the plunger was able to move during the fill.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event cannot be confirmed.There was no confirmation on what the customer indicated because the syringe was filled with water and no problems were noted, the plunger was able to move during the fill.Additionally, after analysis it was determined that the needle's gauge returned at 10 atm.This problem is likely due to the manipulation of the device.A hit or excessive pressure during the usage may have caused the reported and encountered problem.Forcing the device against significant resistance could result in device damage or loss of functionality.Therefore, the most probable root cause is adverse event related to procedure.

Event Description

It was reported to boston scientific corporation that an alliance inflation syringe was being prepared for use in a procedure performed on an unknown date.During preparation, when trying to fill the syringe, it was unable to pull back the plunger and it was completely stuck.The procedure was completed with another alliance inflation syringe.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of gauge reading inaccurate.Please see block h10 for full investigation details.

• 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: 17393560
• MDR Text Key: 320138319
• Report Number: 3005099803-2023-03974
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729746737
• UDI-Public: 08714729746737
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2023

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 Model Number: M00550600
• Device Catalogue Number: 5060-05S
• Device Lot Number: 0030392649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2023
• Initial Date Manufacturer Received: 07/04/2023
• Initial Date FDA Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1