MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK 10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE; SYRINGE, BALLOON INFLATION

Model Number M00550600

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

This report pertains to one of two devices used during the same procedure.Manufacturer report# 3005099803-2018-01027 pertains to the first alliance inflation syringe device and manufacturer report# 3005099803-2018-01028 pertains to the second alliance inflation syringe device.It was reported to boston scientific corporation that two alliance inflation syringes were used during an esophagogastroduodenoscopy (egd) with dilation procedure performed in the esophagus on (b)(6) 2018.According to the complainant, during the procedure, the gauge of the syringe would not register any pressure when pressure was applied to the balloon.The same issue happened with the second alliance inflation syringe.The procedure was completed with a different, non-bsc device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: 10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7434354
• MDR Text Key: 105697513
• Report Number: 3005099803-2018-01028
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729746737
• UDI-Public: 08714729746737
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2020
• Device Model Number: M00550600
• Device Catalogue Number: 5060-05S
• Device Lot Number: 21610691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1