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

Model Number 2800

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2019

Event Type  malfunction  

Event Description

It was reported that foreign material was present on the device.While the customer was stocking the shelves with inventory, an encore 26 advantage kit was noted to have a loose black floating fuzzy spec that moved within the sterile packaging of the device.There was no patient involvement.

Manufacturer Narrative

The device was received inside an un-opened pouch which also contained foreign matter.No visual defects were observed in the device.Dimensional inspection was performed comparing the foreign matter found inside the packaging against the tappi chart.The foreign matter was measured at over 5.00mm.

Event Description

It was reported that foreign material was present on the device.While the customer was stocking the shelves with inventory, an encore 26 advantage kit was noted to have a loose black floating fuzzy spec that moved within the sterile packaging of the device.There was no patient involvement.

• 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: 9468603
• MDR Text Key: 170793603
• Report Number: 2134265-2019-15555
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729127048
• UDI-Public: 08714729127048
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

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: 09/22/2021
• Device Model Number: 2800
• Device Catalogue Number: 2800
• Device Lot Number: 0024475711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: 03/18/2020
• Supplement Dates FDA Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1