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

Model Number	3040
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2022
Type of Reportable Event	Malfunction
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 encore ic passed the test.A vacuum test was conducted, there was no bubble leakage observed.The encore ic passed side load testing.The encore ic device locking mechanism test was performed, it was found that when the plunger handle was rotated the needle did not return to zero.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2022.It was reported that the air pressure did not rise.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery.An encore 26 was selected for use.During the procedure, it was noted that the air pressure does not rise during the process of expanding the lesion.There were no patient complications reported.However, device analysis revealed that when the plunger handle was rotated the needle did not return to zero.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15558115
• Report Number: 2134265-2022-08845
• Device Sequence Number: 7046118
• Product Code: MAV
• UDI-Device Identifier: 08714729177029
• UDI-Public: 08714729177029
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 10/06/2022

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
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 72 YR
• Patient Sex: Female