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

Model Number M00550600

Device Problem Pressure Problem (3012)

Patient Problem Insufficient Information (4580)

Event Date 08/04/2021

Event Type  malfunction  

Event Description

Boston scientific alliance ii single-use syringe/gauge assembly malfunctioned during a medical procedure as it was unable to keep pressure.

Event Description

Boston scientific alliance ii single-use syringe/gauge assembly malfunctioned during a medical procedure as it was unable to keep pressure.

• 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: 12405074
• MDR Text Key: 269361891
• Report Number: 12405074
• Device Sequence Number: 1
• Product Code: MAV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

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: No Information
• Device Model Number: M00550600
• Device Catalogue Number: M00550600
• Device Lot Number: 26503980
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2021
• Date Report to Manufacturer: 09/01/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/02/2021
• Patient Sequence Number: 1
• Patient Age: 21535 DA