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

Model Number M00550600

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 08/09/2022

Event Type  malfunction  

Event Description

Boston scientific alliance ii single-use syringe plastic end piece broke off.Was not able to deflate balloon.

• 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: 15347289
• MDR Text Key: 299155544
• Report Number: 15347289
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/24/2022

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 Lot Number: 29014364
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Race: White