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

Model Number 2760

Device Problem Defective Device (2588)

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

Event Date 05/01/2023

Event Type  malfunction  

Manufacturer Narrative

B3 date of event was estimated based on the initial notification date as the event date was not reported.The device was returned for analysis.Visual inspection revealed the gauge needle was at 10 atm when received and was unable to be returned to 0.The device presented a contrast media in the tube.Functional testing could not be performed due to the device was unable to be returned to 0.

Event Description

It was reported that a device issue occurred.An encore 26 advantage kit was selected for use.During the procedure, it was noted that the inflator was unable to function properly.No patient complications were reported.However, device analysis revealed the gauge could not zero.

Manufacturer Narrative

B5 describe event and problem and g3 bsc aware date: corrected.B3 date of event was estimated based on the initial notification date as the event date was not reported.The device was returned for analysis.Visual inspection revealed the gauge needle was at 10 atm when received and was unable to be returned to 0.The device presented a contrast media in the tube.Functional testing could not be performed due to the device was unable to be returned to 0.

Event Description

Reportable based on device analysis completed on 30nov2023.It was reported that a device issue occurred.An encore 26 advantage kit was selected for use.During the procedure, it was noted that the inflator was unable to function properly.No patient complications were reported.However, device analysis revealed the gauge could not zero.The device was returned for analysis.Visual inspection revealed the gauge needle was at 10 atm when received and was unable to be returned to 0.The device presented a contrast media in the tube.Functional testing could not be performed due to the device was unable to be returned to 0.

• Brand Name: ENCORE 26 ADVANTAGE KIT
• Type of Device: 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 ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18261099
• MDR Text Key: 329681410
• Report Number: 2124215-2023-68580
• Device Sequence Number: 1
• Product Code: MAV
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K140745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2760
• Device Catalogue Number: 2760
• Device Lot Number: 0030935604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2023
• 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