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	10/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that gauge inaccuracy occurred.The 90% stenosed target lesion was located in the moderately tortuous and calcified shunt.An encore 26 inflation device was selected for use.It was noted that the balloon inflated, however, the pressure gauge only reached 25 atmospheres.It did not increase up to 26 atmospheres when more pressure was applied.The procedure was completed using this device.There were no patient complications reported post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer.The encore ic was returned for analysis.A visual inspection was conducted, and the encore ic did not have any visual defects.The gauge needle was at 0 atm when received.A pressure damping test was conducted and the unit passed the test.A vacuum test was conducted, the vacuum was created, and no bubble leakage was observed.The encore ic passed side load testing.The gauge accuracy test was performed and concluded that the device's gauge was giving an inaccurate reading when it was being pressurized at 13 and 26 atmospheres.The device locking mechanism test was performed, and no issues were noted.No other issues were identified during the product analysis.Based on the evidence, the as reported code of, gauge reading inaccurate, can be confirmed due to the reading inaccuracy when the device was pressurized under 13 and 26 atmospheres.
Event or Problem Description
It was reported that gauge inaccuracy occurred.The 90% stenosed target lesion was located in the moderately tortuous and calcified shunt.An encore 26 inflation device was selected for use.It was noted that the balloon inflated, however, the pressure gauge only reached 25 atmospheres.It did not increase up to 26 atmospheres when more pressure was applied.The procedure was completed using this device.There were no patient complications reported post procedure.

• Brand Name: ENCORE 26
• Common Device Name: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20571144
• Report Number: 2124215-2024-67264
• Device Sequence Number: 20889606
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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: 04/11/2026
• Device Model Number: 3040
• Device Catalogue Number: 3040
• Device Lot Number: 0033805037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• 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