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

Model Number M00550601

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 03/07/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0902 captures the reportable event of gauge reading inaccurate.

Event Description

It was reported to boston scientific corporation that an alliance ii inflation syringe was used in the esophagus during a balloon dilation procedure performed on (b)(6) 2024.During the procedure, the customer reported that the pressure gauge needle was pointing in a negative position before inflation began.The procedure was completed with the original device.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that an alliance ii inflation syringe was used in the esophagus during a balloon dilation procedure performed on march 7, 2024.During the procedure, the customer reported that the pressure gauge needle was pointing in a negative position before inflation began.The procedure was completed with the original device.No further information has been obtained despite good faith efforts.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 ii inflation syringe was analyzed, and it was found that the device returned with an inaccurate reading as the needle was above the upper limit at 12 atm.A functional test was attempted, but the gauge needle could not advance, and the functional test could not be successfully performed.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of gauge reading inaccurate was confirmed.The results of the visual analysis performed on the returned device found that the gauge needle was above the upper limit, at 12 atm.No visible physical damage was found on the device therefore, it is unclear what conditions led to the gauge reading inaccurately.Maybe the way in which the device was handled and manipulated such as a possible hit or accidental drop of the device could have caused the gauge needle problem found on the returned device.Therefore, the most probable root cause is cause not established.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19020867
• MDR Text Key: 339229783
• Report Number: 3005099803-2024-01280
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00550601
• Device Catalogue Number: 5060-05
• Device Lot Number: 0032483502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2023
• 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