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

Model Number 2760

Device Problem Contamination (1120)

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

Event Date 08/05/2021

Event Type  malfunction  

Event Description

It was reported that the device was contaminated.An encore 26 advantage kit was selected for a percutaneous coronary intervention (pci).During the procedure, the device was used to inflate the percutaneous transluminal coronary angioplasty balloons.During post dilatation, small metallic particles were found after the chamber was filled.Contrast and heparinized saline was added.The source of the particles is unknown.The procedure was completed with another device.The patient's status was stable.

Event Description

It was reported that the device was contaminated.An encore 26 advantage kit was selected for a percutaneous coronary intervention (pci).During the procedure, the device was used to inflate the percutaneous transluminal coronary angioplasty balloons.During post dilatation, small metallic particles were found after the chamber was filled.Contrast and heparinized saline was added.The source of the particles is unknown.The procedure was completed with another device.The patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: the unit was returned in a generic plastic bag with batch 27392658 printed on it.The device was returned with an amount of saline solution within the barrel of the device; however, after a complete visual and microscopic inspection, no contaminant agents or foreign matters were observed within the encore device.

• 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
• MDR Report Key: 12384210
• MDR Text Key: 268682257
• Report Number: 2134265-2021-10892
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729180005
• UDI-Public: 08714729180005
• Combination Product (y/n): N
• PMA/PMN Number: K140745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2023
• Device Model Number: 2760
• Device Catalogue Number: 2760
• Device Lot Number: 0027392658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1