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).The device has not been received for analysis.Upon receipt and 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.Udi= (b)(4).

Event Description

It was reported to boston scientific corporation that an alliance ii inflation syringe was used during an esophageal dilatation procedure performed on an unknown date.According to the complainant, during the procedure, the gauge needle did not move from 0atm when pressure was applied.It was noted that it was unclear if the issue was due to a balloon malfunction or gauge malfunction, but the customer believes it seemed like the gauge.The procedure was completed with another alliance syringe.There were no patient complications reported as a result of this event.

Manufacturer Narrative

A visual examination of the complaint device revealed that the needle of the gauge was at 0 atm.A functional evaluation was performed and the gauge needle would not move above 0 atm.Based on the condition of the returned device, the reported defect of gauge reading inaccurate was confirmed.The noted defect likely occurred due to handling of the device or portion of the device without direct patient contact either during shipping, unpacking or preparation of the device for 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 ii inflation syringe was used during an esophageal dilatation procedure performed on an unknown date.According to the complainant, during the procedure, the gauge needle did not move from 0atm when pressure was applied.It was noted that it was unclear if the issue was due to a balloon malfunction or gauge malfunction, but the customer believes it seemed like the gauge.The procedure was completed with another alliance syringe.There were no patient complications reported as a result of this 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: 5933001
• MDR Text Key: 54082701
• Report Number: 3005099803-2016-02703
• 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: 08/26/2016

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: 07/01/2018
• Device Model Number: M00550601
• Device Catalogue Number: 5060-05
• Device Lot Number: 0019436897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2016
• Initial Date FDA Received: 09/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2016
• 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