MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK ENCORE BALLOON CATHETER INFLATION DEVICE; SYRINGE, BALLOON INFLATION

Model Number M001151050

Device Problems Contamination (1120); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 01/26/2016

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by manufacturer: the device was returned for analysis.An empty opened tray was returned for the reported.During visual analysis it was noted that a section of the (b)(6) lid was still attached to the tray, indicating that the package was difficult to open.The (b)(6) lid was torn and frayed, however no fibres/particles were found inside the tray.As the encore device was not returned with the packaging the presence of fibers on the device could not be confirmed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is user preference issue as device meets specification however the user is dissatisfied with the function, performance, and the appearance of the product.(b)(4).

Event Description

It was reported that the sterility was compromised.A 26 encore balloon catheter inflation device was selected for use.During preparation, when the device was removed from the box, it was noted that the bonding part of the plastic case containing the device was unable to peel off appropriately and paper inside the cover caused fibers, making the device unclean.The procedure was completed with another of the same device.No patient complications were reported and patient condition was good.

• Brand Name: ENCORE BALLOON CATHETER INFLATION DEVICE
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5458292
• MDR Text Key: 38990913
• Report Number: 2134265-2016-00977
• Device Sequence Number: 1
• Product Code: MAV
• Combination Product (y/n): N
• PMA/PMN Number: K955869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: M001151050
• Device Catalogue Number: 15-105
• Device Lot Number: 0018570178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2015
• 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