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 Date 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

This report pertains to one of five alliance syringe used during the same procedure.Manufacturer report# 3005099803-2017-02937 pertains to the first device, manufacturer report# 3005099803-2017-02940 pertains to the second device, manufacturer report# 3005099803-2017-02941 pertains to the third device, manufacturer report# 3005099803-2017-02942 pertains to the fourth device and manufacturer report# 3005099803-2017-02943 pertains to the fifth device.It was reported to boston scientific corporation that five alliance inflation syringes were used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, a balloon was inflated using the alliance inflation syringe.However, the gauge did not accurately register the pressure as the balloon was being inflated.It was noted that an attempt to inflate to 20 atm was made but the gauge needle would not go past 18-19 atm.The following four syringes had the same issue, and the procedure was completed with another alliance inflation syringe.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.

Manufacturer Narrative

A visual examination of the complaint device revealed that there was no issue with the device.The device was returned with the gauge needle at 0 atm.A functional evaluation was performed with a pressure druck, the alliance was filled with water and pressure was applied to the pressure druck.The device gauge read correctly.The returned device showed no evidence of either the alleged issue or any other defect which could have contributed to the event (visual, physical and performance testing).Therefore the root cause for this complaint cannot be confirmed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

Note: this report pertains to one of five alliance syringe used during the same procedure.Manufacturer report# 3005099803-2017-02937 pertains to the first device, manufacturer report# 3005099803-2017-02940 pertains to the second device, manufacturer report# 3005099803-2017-02941 pertains to the third device, manufacturer report# 3005099803-2017-02942 pertains to the fourth device and manufacturer report# 3005099803-2017-02943 pertains to the fifth device.It was reported to boston scientific corporation that five alliance inflation syringes were used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, a balloon was inflated using the alliance inflation syringe.However, the gauge did not accurately register the pressure as the balloon was being inflated.It was noted that an attempt to inflate to 20 atm was made but the gauge needle would not go past 18-19 atm.The following four syringes had the same issue, and the procedure was completed with another alliance inflation syringe.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: 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: 6925979
• MDR Text Key: 89939828
• Report Number: 3005099803-2017-02940
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729129332
• UDI-Public: 08714729129332
• 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,Followup
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2019
• Device Model Number: M00550601
• Device Catalogue Number: 5060-05
• Device Lot Number: 0020784732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2017
• 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