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 04/08/2024

Event Type  malfunction  

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.It was reported that the device was not used past its expiry date.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 attempted to be used in the esophagus during an esophageal dilatation procedure performed on (b)(6) 2024.During the procedure, pressure was applied on the balloon, but the gauge was not working.The procedure was completed with another alliance ii inflation syringe.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 attempted to be used in the esophagus during an esophageal dilatation procedure performed on (b)(6) 2024.During the procedure, pressure was applied on the balloon, but the gauge was not working.The procedure was completed with another alliance ii inflation syringe.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.It was reported that the device was not used past its expiry date.Block h6: imdrf device code a0902 captures the reportable event of gauge reading inaccurate.Block h11: investigation results: the returned alliance ii inflation syringe was analyzed, and a visual inspection found the extension tube of the device was not returned.Visual inspection of the syringe of the device found no damages.Functional inspection was performed by filling the syringe with water and pressurizing it to 10 atm for 30 seconds.The gauge readings were accurate during functional testing.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.No damages were found on the returned device during visual inspection.The results of the functional analysis performed on the returned device found that the device was able to be pressurized to 10 atm for 30 seconds and the gauge read accurately.Therefore, the most probable root cause is no problem detected.

• 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: 19210161
• MDR Text Key: 341365300
• Report Number: 3005099803-2024-01931
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2024

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: M00550601
• Device Catalogue Number: 5060-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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