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

Model Number	3040
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the gauge inaccuracy occurred.The target lesion was located in the left anterior descending artery.A 26 encore inflation device was selected for use.During the procedure, as positive pressure was applied from 12atm to 14atm, the gauge needle suddenly turned 360 degrees clockwise.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition was stable.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by manufacturer: the device was returned for analysis.The gauge needle was at 0 atm when received.No visual defects were encountered in the device.A functional test of the complaint device was carried out using a bsc stopcock.The unit passed all functional tests; no leaks nor damages in the device were noted.
Event or Problem Description
It was reported that the gauge inaccuracy occurred.The target lesion was located in the left anterior descending artery.A 26 encore inflation device was selected for use.During the procedure, as positive pressure was applied from 12atm to 14atm, the gauge needle suddenly turned 360 degrees clockwise.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition was stable.

• Brand Name: ENCORE 26
• Common Device Name: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8807579
• Report Number: 2134265-2019-08478
• Device Sequence Number: 320102
• Product Code: MAV
• UDI-Device Identifier: 08714729177029
• UDI-Public: 08714729177029
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K955869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

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: 04/08/2021
• Device Model Number: 3040
• Device Catalogue Number: 3040
• Device Lot Number: 0023617639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR