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

Model Number 2800

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/11/2024

Event Type  malfunction  

Event Description

It was reported that foreign material was observed on the device.Following opening of the package, a black hair was noted on the encore 26 locking button.The device was not used.The procedure was completed with a replacement device and no patient complications were reported.

Manufacturer Narrative

The returned product consisted of the encore ic device.The device was returned with its original pouch and overall visual review did not identify failures or evidence that could be lost due to decontamination process.The gauge needle was at 0 atm when received.There was no visual evidence of a black hair on the yellow button of the device.Based on the device investigation, the reported event could not be confirmed.

Event Description

It was reported that foreign material was observed on the device.Following opening of the package, a black hair was noted on the encore 26 locking button.The device was not used.The procedure was completed with a replacement device and no patient complications were reported.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18619446
• MDR Text Key: 334281046
• Report Number: 2124215-2024-05460
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729127048
• UDI-Public: 08714729127048
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2800
• Device Catalogue Number: 2800
• Device Lot Number: 0032474440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1