MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENCORE 26; SYRINGE, BALLOON INFLATION

Model Number	3040
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the gauge needle would not go up.An encore 26 inflation device was selected for use.During procedure, it was noted that the gauge needle was strange as it would not go up even if the balloon was inflating.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
(b)(6).

• Brand Name: ENCORE 26
• Common Device Name: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13101625
• Report Number: 2134265-2021-16273
• Device Sequence Number: 11685701
• Product Code: MAV
• UDI-Device Identifier: 08714729177029
• UDI-Public: 08714729177029
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/28/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/06/2023
• Device Model Number: 3040
• Device Catalogue Number: 3040
• Device Lot Number: 0028150392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown