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 01/04/2024

Event Type  malfunction  

Event Description

Note: this report pertains to one of two alliance ii inflation syringes used during the same procedure.It was reported to boston scientific corporation that two alliance ii inflation syringes were used in the esophagus during an upper gastrointestinal balloon dilation procedure performed on (b)(6) 2024.During the procedure, while inflating the cre dilation balloon at the target site, when pressure of more than 3 atm was applied the balloon dilation did not proceed.After repeated attempts, the balloon finally dilated when pressure was applied more gently than usual.The customer reported that there was an inconsistency between the dilation pressure and balloon size.The same problem occurred with the second alliance ii inflation syringe.The procedure was completed with another alliance ii inflation syringe.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.The reported event may suggest that the alliance ii inflation syringe pressure gauge was reading inaccurately.

Manufacturer Narrative

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

Event Description

Note: this report pertains to one of two alliance ii inflation syringes used during the same procedure.It was reported to boston scientific corporation that two alliance ii inflation syringes were used in the esophagus during an upper gastrointestinal balloon dilation procedure performed on (b)(6) 2024.During the procedure, while inflating the cre dilation balloon at the target site, when pressure of more than 3 atm was applied the balloon dilation did not proceed.After repeated attempts, the balloon finally dilated when pressure was applied more gently than usual.The customer reported that there was an inconsistency between the dilation pressure and balloon size.The same problem occurred with the second alliance ii inflation syringe.The procedure was completed with another alliance ii inflation syringe.There were no patient complications reported as a result of this event.Additional information received on february 7, 2024.The balloon was able to be inflated however, the gauge would not move.

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 a visual examination found no damages to the device.Functional analysis was performed, and the syringe was filled with water and pressurized to 10 atm for 30 seconds.The syringe was able to hold the pressure.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of gauge reading inaccurate was not confirmed.The results of the analysis performed on the returned device found that the syringe was filled with water and pressurized to 10 atm for 30 seconds.The syringe was able to hold the pressure.Also, the device met all the manufacturing requirements, and it passed the visual and dimensional inspections during the product analysis.Therefore, the most probable root cause is no problem detected.Block h11 (additional information): block b5 (describe event or problem) have been updated.

• 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: 18591534
• MDR Text Key: 334499007
• Report Number: 3005099803-2024-00152
• Device Sequence Number: 1
• Product Code: MAV
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• 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: 0032062004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2023
• 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