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

Model Number 2800

Device Problems Defective Device (2588); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.Device evaluated by mfr: the device was returned for analysis.An opened cardboard box was received for this complaint.The box was severely damaged, it was wrinkled and some sections of it were torn.The box contained 5 encore devices inside.The trays of the devices were damaged and due to the damages, the sterility of the devices was compromised.The devices did not show visual damages.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 20oct2020.It was reported that upon receipt, the encore 26 inflation device box was found damaged along with the product inside.There was no patient involvement however, device analysis revealed that the sterility of the device was compromised.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10817708
• MDR Text Key: 215545954
• Report Number: 2134265-2020-14973
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729127048
• UDI-Public: 08714729127048
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2022
• Device Model Number: 2800
• Device Catalogue Number: 2800
• Device Lot Number: 0025720505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2020
• 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