MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP ALLIANCE II SINGLE USE SYRINGE/GAUGE ASSEMBLY; SYRINGE BALLOON INFLATION

Model Number GTIN 08714729746737

Device Problems Inflation Problem (1310); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2015

Event Type  malfunction  

Event Description

When attempted to inflate the cre balloon with the inflation syringe, the pressure gauge on the syringe filled with fluid (nacl) from the syringe.The balloon was inflated within the pressure range indicated on the label.The cre balloon wire was intact; the inflation gun was not affected.Only the inflation syringe was defective.No patient harm.

• Brand Name: ALLIANCE II SINGLE USE SYRINGE/GAUGE ASSEMBLY
• Type of Device: SYRINGE BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 4761717
• MDR Text Key: 21935868
• Report Number: 4761717
• Device Sequence Number: 1
• Product Code: MAV
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: GTIN 08714729746737
• Device Catalogue Number: M00550600
• Device Lot Number: 1768607
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/23/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2015
• Patient Sequence Number: 1
• Patient Age: 72 YR