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 05/30/2016

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.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.

Event Description

It was reported to boston scientific corporation that an alliance inflation syringe was used during a bile duct stenting procedure performed on (b)(6) 2016.According to the complainant, during the preparation, the gauge was foggy and was difficult to read.They continued to use the device and dilated the stricture; however, the plastic gauge cover cracked and detached.The procedure was completed at this time.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be good.

Manufacturer Narrative

Investigation results: a visual examination of the complaint device revealed that the gauge cover was detached from the device and was noted to be cloudy.The gauge needle was at 0 atm.The gauge cover was reattached and a functional evaluation was performed.The device was pressurized to 10atm for 30 seconds with no issues noted; however, when the pressure was released, the gauge cover again detached from the device.Based on the condition of the returned device, 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.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 a bile duct stenting procedure performed on (b)(6) 2016.According to the complainant, during the preparation, the gauge was foggy and was difficult to read.They continued to use the device and dilated the stricture; however, the plastic gauge cover cracked and detached.The procedure was completed at this time.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be good.

• 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: 5733160
• MDR Text Key: 47699811
• Report Number: 3005099803-2016-01735
• Device Sequence Number: 1
• Product Code: MAV
• Combination Product (y/n): N
• PMA/PMN Number: K922573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2016

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: 11/01/2017
• Device Model Number: M00550601
• Device Catalogue Number: 5060-05
• Device Lot Number: 18583282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2016
• Initial Date FDA Received: 06/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2015
• 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