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

(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.(b)(4).

Event Description

This report pertains to one of two alliance syringe used during the same procedure.Manufacturer report# 3005099803-2017-03225 pertains to the first device, manufacturer report# 3005099803-2017-03226 pertains to the second device.It was reported to boston scientific corporation that two alliance inflation syringes were used in the esophagus during an esophagogastroduodenoscopy (egd) with dilation procedure performed on an unknown date.According to the complainant, during the procedure, a balloon was inflated using the alliance inflation syringe; however, the gauge did not register a change in pressure as the balloon inflated.The same issue happened with the second syringe.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 stable.

Manufacturer Narrative

Investigation results: a visual examination of the complaint device revealed that the device does not have visual defects.The gauge needle was at 0 atm when received.A functional evaluation was performed to pressurize the device to 10 atm with 35 ml of water for 30 seconds.No issues were noted with the gauge needle during functional analysis.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.A search of the complaint database revealed that no other complaints exist for the specified lot.

Event Description

This report pertains to one of two alliance syringe used during the same procedure.Manufacturer report# 3005099803-2017-03225 pertains to the first device, manufacturer report# 3005099803-2017-03226 pertains to the second device.It was reported to boston scientific corporation that two alliance inflation syringes were used in the esophagus during an esophagogastroduodenoscopy (egd) with dilation procedure performed on an unknown date.According to the complainant, during the procedure, a balloon was inflated using the alliance inflation syringe; however, the gauge did not register a change in pressure as the balloon inflated.The same issue happened with the second syringe.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 stable.

• 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: 6966492
• MDR Text Key: 90677342
• Report Number: 3005099803-2017-03225
• 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,Followup
• Report Date: 09/27/2017

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: 08/21/2019
• Device Model Number: M00550601
• Device Catalogue Number: 5060-05
• Device Lot Number: 21032338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2017
• Initial Date FDA Received: 10/20/2017
• Supplement Dates Manufacturer Received: 10/26/2017
• Supplement Dates FDA Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2017
• 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