MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALLIANCE II; SYRINGE, BALLOON INFLATION

Model Number M00550600

Device Problems Inflation Problem (1310); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

Note: this report pertains to one of two alliance syringe used during the same procedure.It was reported to boston scientific corporation that two alliance syringes were used in the esophagus during an esophageal dilation procedure performed on (b)(6) 2022 during the procedure, the balloon was unable to inflate.The same problem occurred with the second alliance syringe.Reportedly, the procedure was rescheduled at this time.There were no patient complications reported as a result of this event.

Event Description

Note: this report pertains to one of two alliance syringe used during the same procedure.It was reported to boston scientific corporation that two alliance syringes were used in the esophagus during an esophageal dilation procedure performed on (b)(6) 2022 during the procedure, the balloon was unable to inflate.The same problem occurred with the second alliance syringe.Reportedly, the procedure was rescheduled at this time.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: device code a27 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: investigation results a visual examination of the returned complaint device found that the device had no damages.The extension tube of the device was not returned.Functional evaluation was performed the syringe was inflated with water and held the pressure to 10 atm.The most probable root cause is manufacturing deficiency, as the reported failure was traced to the manufacturing process.An investigation to address this issue has been completed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: ALLIANCE II
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14210605
• MDR Text Key: 290096374
• Report Number: 3005099803-2022-02321
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729746737
• UDI-Public: 08714729746737
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2022

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: 12/14/2023
• Device Model Number: M00550600
• Device Catalogue Number: 5060-05S
• Device Lot Number: 0028555032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 04/26/2022
• Supplement Dates Manufacturer Received: 05/09/2022
• Supplement Dates FDA Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1