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

Model Number	2760
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
Type of Reportable Event	Malfunction
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12384210
• Report Number: 2134265-2021-10892
• Device Sequence Number: 11924317
• Product Code: MAV
• UDI-Device Identifier: 08714729180005
• UDI-Public: 08714729180005
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1