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 04/01/2024

Event Type  malfunction  

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.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 during a procedure performed on unknown date.During the procedure, the pressure was not rising.The procedure was completed with another alliance ii inflation syringe.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 b3: approximated based on the date the manufacturer became aware of the event.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 that the gauge needle was above the upper limit which is 12 atm.Functional testing was attempted to be performed but due to the returned device with the needle above the upper limit, the gauge needle could not advance further.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 analysis performed on the returned device found that the needle was above the upper limit, which is 12 atm, therefore with an inaccurate reading.It is possible that the way in which the device was handled and manipulated may have caused the encountered problem.Such as a possible hit on the gauge or an accidental drop of the device.Therefore, the most probable root cause is an adverse event related to procedure.

Event Description

It was reported to boston scientific corporation that an alliance ii inflation syringe was attempted to be used during a procedure performed on unknown date.During the procedure, the pressure was not rising.The procedure was completed with another alliance ii inflation syringe.No further information has been obtained despite good-faith efforts.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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19203210
• MDR Text Key: 341295546
• Report Number: 3005099803-2024-01929
• 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
• 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
• Device Lot Number: 0032483506
• 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
• 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