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

Model Number M00550600

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 01/05/2023

Event Type  malfunction  

Manufacturer Narrative

Imdrf device code a0902 captures the reportable event of gauge reading inaccurate.

Event Description

Note: this report pertains to one of two alliance syringe used in the same patient and procedure.It was reported to boston scientific corporation that an alliance inflation syringe was used during an enteral dilation procedure on (b)(6) 2023.Prior to procedure, the needle did not move even though pressure was applied.The procedure was completed with another alliance inflation syringe.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device 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 no damages to the syringe.The extension tube of the device was not returned.A functional inspection was performed and the syringe was connected to an alliance inflation system.The syringe was filled with water, pressurized to 10 atm for 30 seconds and the pressure reading was accurate.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.Therefore, the most probable root cause is no problem detected.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.

Event Description

Note: this report pertains to one of two alliance syringe used in the same patient and procedure.It was reported to boston scientific corporation that an alliance inflation syringe was used during an enteral dilation procedure on (b)(6) 2023.Prior to procedure, the needle did not move even though pressure was applied.The procedure was completed with another alliance inflation syringe.There were no patient complications reported as a result of this 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: 16292741
• MDR Text Key: 308845952
• Report Number: 3005099803-2023-00357
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729746737
• UDI-Public: 08714729746737
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• 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 Model Number: M00550600
• Device Catalogue Number: 5060-05S
• Device Lot Number: 0030126977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 02/03/2023
• Supplement Dates Manufacturer Received: 02/14/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2022
• 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