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

Model Number 25335

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 08/04/2021

Event Type  malfunction  

Event Description

It was reported that a gauge inaccuracy occurred.A 70% stenosed target lesion was located in the left vertebral artery.An encore 26 inflation device was selected for use.During the procedure, it was noted that the gauge needle failed to point the correct data and failed to control the attached balloon.No patient complications were reported and patient was stable.

Event Description

It was reported that a gauge inaccuracy occurred.A 70% stenosed target lesion was located in the left vertebral artery.An encore 26 inflation device was selected for use.During the procedure, it was noted that the gauge needle failed to point the correct data and failed to control the attached balloon.No patient complications were reported and patient was stable.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Visual inspection revealed that the gauge needle was at 0 atm when received.The device did not have visual defects.Functional testing of the complaint device (pressure damping test, vacuum test, side load test, gauge accuracy test, device locking mechanism test) was carried out and the unit passed all functional tests without issues.

• Brand Name: ENCORE 26
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12451307
• MDR Text Key: 270771845
• Report Number: 2134265-2021-11259
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729183624
• UDI-Public: 08714729183624
• Combination Product (y/n): N
• PMA/PMN Number: K955869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2023
• Device Model Number: 25335
• Device Catalogue Number: 25335
• Device Lot Number: 0026903992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 10/04/2021
• Supplement Dates FDA Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 70