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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/19/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Note: this report pertains to one of three alliance inflation syringes used in the same patient and procedure.It was reported to boston scientific corporation that three alliance inflation syringes were used during a sphincteroplasty and endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the balloon was reported to be filling okay.However, the gauge on the alliance inflation syringe never moved.Two further syringes from the same lot number were tried and had the same problem.The procedure was completed with a fourth alliance inflation syringe with different lot number.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a0902 captures the reportable event of gauge reading inaccurate.Block h10: investigation results: the device has not been received despite good faith efforts to obtain product return.As such, physical analysis has not been conducted in our laboratory.However, a device history review was performed and determined that, based on the manufacturing date of the device, the gauge reading inaccurately was likely the result of the manufacturing process.With all the available information, although the device has not been returned, boston scientific determined that the gauge reading inaccurately was likely the result of 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 (b)(6) 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 (b)(6) 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.Block h11 correction: block d7a (sud reprocessed and reused), h6 (evaluation conclusion codes), h8 (usage of device) have been updated.

Event Description

Note: this report pertains to one of three alliance inflation syringes used in the same patient and procedure.It was reported to boston scientific corporation that three alliance inflation syringes were used during a sphincteroplasty and endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the balloon was reported to be filling okay.However, the gauge on the alliance inflation syringe never moved.Two further syringes from the same lot number were tried and had the same problem.The procedure was completed with a fourth alliance inflation syringe with different lot number.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: 17909737
• MDR Text Key: 325358253
• Report Number: 3005099803-2023-05424
• Device Sequence Number: 1
• Product Code: MAV
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 02/29/2024

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: M00550600
• Device Catalogue Number: 5060-05S
• Device Lot Number: 0031929478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 02/08/2024
• Supplement Dates FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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