MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK ALLIANCE¿ II; SYRINGE, BALLOON INFLATION

Model Number M00550601

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Reported event of gauge reading inaccurately.Visual evaluation of the complaint device was performed and there were no issues noted.A functional test was performed and found that the gauge needle was unable to move above 0atm when attempting to pressurize the device to 10atm for 30 seconds.It is probable that the device was mishandled during storage of the device in the hospital or during preparation of the device during the procedure.This could have led to the gauge receiving a shock causing damage to the internal mechanism of the gauge which would result in the gauge not operating to its specifications.Therefore, the most probable root cause of this complaint is handling damage.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.

Event Description

It was reported to boston scientific corporation that an alliance inflation syringe was used during an esophagogastroduodenoscopy (egd) procedure performed on an unknown date.According to the complainant, during the procedure, the syringe was unable to inflate the balloon.The procedure was completed with another alliance ii inflation syringe.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be fine.Investigation results revealed the gauge was reading inaccurately, therefore, this is now an mdr reportable event.

• Brand Name: ALLIANCE¿ II
• 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: 5812052
• MDR Text Key: 50100346
• Report Number: 3005099803-2016-02006
• Device Sequence Number: 1
• Product Code: MAV
• 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: 06/29/2016

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 Expiration Date: 04/25/2018
• Device Model Number: M00550601
• Device Catalogue Number: 5060-05
• Device Lot Number: 0019185186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2016
• Initial Date FDA Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2016
• 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