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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that an alliance inflation syringe was used in the esophagus during a esophageal balloon dilation procedure performed on (b)(6) 2022.During procedure, it was noticed that the pressure gauge could not read the pressure index value correctly and there was liquid leakage at the front end of the device.The procedure was completed with another alliance inflation syringe.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation that an alliance inflation syringe was used in the esophagus during a esophageal balloon dilation procedure performed on (b)(6), 2022.During procedure, it was noticed that the pressure gauge could not read the pressure index value correctly and there was liquid leakage at the front end of the device.The procedure was completed with another alliance inflation syringe.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: device code a0902 captures the reportable event of reading inaccurate.Block h10: investigation results the returned alliance inflation syringe was analyzed, and a visual evaluation found that the tip of luer lock broken and friction marks on the luer lock.Microscopic inspection found the tip of luer lock broken and friction marks on the luer lock.A functional inspection could not be performed due to the returned condition of the device.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event gauge reading inaccurate was not confirmed; however, the reported leak was confirmed.The damage found in the device causes that it is not possible to connect any accessories that could cause the leak.It is likely possible that factors encountered during the procedure, due to the manner as the device was handled and manipulated may have caused the reported and encountered failure.Excessive manipulation of the device during the preparation without enough care could have induced the defect found.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.

• 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: 15755702
• MDR Text Key: 307697924
• Report Number: 3005099803-2022-06560
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729129332
• UDI-Public: 08714729129332
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2023

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 Expiration Date: 07/29/2023
• Device Model Number: M00550601
• Device Catalogue Number: 5060-05
• Device Lot Number: 0027750979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 12/23/2022
• Supplement Dates FDA Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2021
• 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
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 62 KG