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

Model Number 3040

Device Problem Inflation Problem (1310)

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

Event Date 05/06/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 307024683
• Report Number: 2134265-2022-08845
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729177029
• UDI-Public: 08714729177029
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K955869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female