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 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

Device code relates to problem code for the reported event of gauge reading inaccurately.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

It was reported to boston scientific corporation that an alliance inflation syringe was used in the esophagus during an endoscopy with dilation procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the gauge needle did not move when pressure was applied.It was noted that this caused the cre balloon to burst.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

Investigation results: a visual examination of the complaint device revealed that the gauge needle was at 0 atm when received and does not show any visual defects.A functional evaluation was performed to pressurize the device to 10 atm with 35 ml of water for 30 seconds.The gauge needle moved from 0 atm in a very slow movement until reach 8 atm, after reaching 8 atm the gauge needle does not advance beyond, although pressure was applied.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 search of the complaint database revealed that no other complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that an alliance inflation syringe was used in the esophagus during an endoscopy with dilation procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the gauge needle did not move when pressure was applied.It was noted that this caused the cre balloon to burst.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: 7160335
• MDR Text Key: 96355162
• Report Number: 3005099803-2017-03892
• 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: 12/11/2017

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: 10/09/2019
• Device Model Number: M00550601
• Device Catalogue Number: 5060-05
• Device Lot Number: 0021233027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 01/04/2018
• Supplement Dates FDA Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2017
• 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
• Patient Age: 64 YR