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

Model Number M00550600

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Perforation (2001)

Event Date 11/01/2023

Event Type  Injury  

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.Imdrf patient code e2114 is being used to capture the reportable event of perforation.Imdrf impact code f23 is being used to capture the reportable event of unexpected medical intervention.

Event Description

Note: this report pertains to one cre pro wireguided dilatation balloon and one alliance inflation syringe used during the same procedure.It was reported to boston scientific corporation that the cre pro wireguided dilatation balloon and alliance inflation syringe were used during a procedure performed on an unknown date.During the procedure, the pressure gauge did not display pressure, the arrow was stuck at 0.Without an indication of pressure, the balloon was overinflated.This caused a perforation in the bypass anastomosis, which was treated using an ovesco clip and an esophageal prosthesis.The procedure was completed with a different model device.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 good.

Event Description

Note: this report pertains to one cre pro wireguided dilatation balloon and one alliance inflation syringe used during the same procedure.It was reported to boston scientific corporation that the cre pro wireguided dilatation balloon and alliance inflation syringe were used during a procedure performed on an unknown date.During the procedure, the pressure gauge did not display pressure, the arrow was stuck at 0.Without an indication of pressure, the balloon was overinflated.This caused a perforation in the bypass anastomosis, which was treated using an ovesco clip and an esophageal prosthesis.The procedure was completed with a different model device.The patient recovered and their current condition is reported to be good.

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.Imdrf patient code e2114 is being used to capture the reportable event of perforation.Imdrf impact code f23 is being used to capture the reportable event of unexpected medical intervention.Block h11 (correction): block b5 (describe event or problem) have been updated.

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.Imdrf patient code e2114 is being used to capture the reportable event of perforation.Imdrf impact code f23 is being used to capture the reportable event of unexpected medical intervention.Block h10: investigation results: the returned alliance ii inflation syringe was analyzed, and a visual examination found no damage to the device.Functional analysis was performed, and the syringe was filled with water and pressurized to 10 atm for 30 seconds however, no reading was made by the device.No other problems with the device were noted.Laboratory analysis confirmed the reported clinical observations.With all the available information, boston scientific (bsc) concludes the reported event of gauge reading inaccurate was confirmed.The returned device was analyzed, and functional testing determined that the syringe could be pressurized successfully but the gauge did not read the pressure.The most probable root cause for this event is manufacturing deficiency, as the gauge reading inaccurately was traced to the manufacturing process.The gauge being unable to read pressure was the result of an intermittently malfunctioning camera system that may not have detected and rejected the faulty device.A review of the manufacturing process identified that a test station had cameras out of focus, which resulted in the inability to detect gauges that did not meet acceptance criteria.Bsc initiated a corrective and preventive action (capa) investigation to determine the root cause of this issue.A review of camera data from (b)(6) 2022 to (b)(6) 2023 identified events where the vision system was intermittently malfunctioning, and alliance ii syringes with faulty gauges may not have been detected.The investigation determined that approximately 0.017% of alliance ii syringes manufactured during this timeframe may have had faulty gauges that were not detected as intended.An inspection was implemented at the test station on 02 august 2023 to confirm vision system functionality.As a result of the capa investigation, bsc implemented a software update on the alliance ii syringe gauge inspection cameras to ensure that all products would be rejected at the test station if the cameras were out of focus.This solution was implemented on 06 december 2023, and there have been no gauge reading inaccurate complaints reported for devices manufactured since the solution was implemented.An investigation to address this problem has been completed.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/product label.

Event Description

Note: this report pertains to one cre pro wireguided dilatation balloon and one alliance inflation syringe used during the same procedure.It was reported to boston scientific corporation that the cre pro wireguided dilatation balloon and alliance inflation syringe were used during a procedure performed on an unknown date.During the procedure, the pressure gauge did not display pressure, the arrow was stuck at 0.Without an indication of pressure, the balloon was overinflated.This caused a perforation in the bypass anastomosis, which was treated using an ovesco clip and an esophageal prosthesis.The procedure was completed with a different model device.The patient recovered and their current condition is reported to be good.

• 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 CORPORATION; 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: 18278357
• MDR Text Key: 329865701
• Report Number: 3005099803-2023-06477
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729746737
• UDI-Public: 08714729746737
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00550600
• Device Catalogue Number: 5060-05S
• Device Lot Number: 0031929478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 02/01/2024; 03/05/2024
• Supplement Dates FDA Received: 02/23/2024; 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2023
• 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
• Patient Outcome(s): Required Intervention