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 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an alliance inflation syringe was used during an esophageal dilatation procedure in the esophagus performed on (b)(6) 2021.During the procedure, it was noted that the gauge would not indicate the correct pressure applied to the balloon.The procedure was completed with this device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: problem code a0902 captures the reportable event of gauge reading inaccurate.Block h10: investigation result a visual examination of the returned complaint device revealed that the device did not have any damages.The gauge needle was at 0 atm when received.Functional evaluation was performed, and the device was pressurized using 35 ml of sterile water until it reached to 10 atm for 30 seconds; there was no issues observed.Based on the analysis performed and the information provided, the most probable root cause for the complaint event is no problem detected since the device complaint or problem cannot be confirmed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

It was reported to boston scientific corporation that an alliance inflation syringe was used during an esophageal dilatation procedure in the esophagus performed on (b)(6) 2021.During the procedure, it was noted that the gauge would not indicate the correct pressure applied to the balloon.The procedure was completed with this device.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
• MDR Report Key: 12435209
• MDR Text Key: 271704250
• Report Number: 3005099803-2021-04593
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729129332
• UDI-Public: 08714729129332
• Combination Product (y/n): N
• PMA/PMN Number: K922573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

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 Expiration Date: 02/11/2023
• Device Model Number: M00550601
• Device Catalogue Number: 5060-05
• Device Lot Number: 0026795377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 09/07/2021
• Supplement Dates FDA Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1