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

Model Number 2760

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 10/12/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter city: (b)(6).

Event Description

It was reported that the gauge needle did not moved down.An encore 26 advantage kit was selected for use.During the procedure, it was noted that the meter part of the indeflator was unusual as the gauge needle did not move down when deflation was performed after pressure was applied to 24 atmospheres.The procedure was completed with another of the same device.There were no patient complications reported.

Event Description

It was reported that the gauge needle did not move down.An encore 26 advantage kit was selected for use.During the procedure, it was noted that the meter part of the indeflator was unusual as the gauge needle did not move down when deflation was performed after pressure was applied to 24 atmospheres.The procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

E1.Initial reporter city: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The gauge needle was at 26 atmospheres (atm) when received.A functional test of the complaint device was carried out using a bsc stopcock.The unit failed all gauge accuracy tests due to inaccurate readings at 13 atm and 26 atm.

• Brand Name: ENCORE 26 ADVANTAGE KIT
• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12752413
• MDR Text Key: 280156947
• Report Number: 2134265-2021-13694
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729180005
• UDI-Public: 08714729180005
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K140745
• 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,Followup
• Report Date: 02/10/2022

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: 05/17/2023
• Device Model Number: 2760
• Device Catalogue Number: 2760
• Device Lot Number: 0027326166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/04/2021
• Supplement Dates Manufacturer Received: 01/22/2022
• Supplement Dates FDA Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2021
• 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
• Treatment: IMAGING CATHETER-BSJ OC; IMAGING CATHETER-BSJ OC; IMAGING CATHETER-BSJ OC