MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC ALLIANCE SYRINGE/GAUGE ASSEMBLY; SYRINGE, BALLOON INFLATION

Model Number M00550600

Device Problems Low Readings (2460); Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Pt undergoing egd(esophagogastroduodenoscopy) with balloon dilation.When pumping up the gun, the gauge did not reading correctly.The balloon pumped up all the way but the gauge did not increase w/ pressure change.

• Brand Name: BOSTON SCIENTIFIC ALLIANCE SYRINGE/GAUGE ASSEMBLY
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 17119410
• MDR Text Key: 317143330
• Report Number: MW5118359
• Device Sequence Number: 1
• Product Code: MAV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00550600
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White