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

Model Number M00566670

Device Problem Unsealed Device Packaging (1444)

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

Event Date 10/20/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an encore 26 inflation device was being prepared for use in a procedure on (b)(6) 2023.During preparation, it was noticed that the packaging was not sealed correctly, and the sterility of the device was compromised.A photo submitted by the customer showed the packaging of the device was not sealed correctly in portions around the perimeter of the package.The procedure was completed with another encore 26 inflation device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a020503 captures the reportable event of seal compromised.

Event Description

It was reported to boston scientific corporation that an encore 26 inflation device was being prepared for use in a procedure on (b)(6) 2023.During preparation, it was noticed that the packaging was not sealed correctly, and the sterility of the device was compromised.A photo submitted by the customer showed the packaging of the device was not sealed correctly in portions around the perimeter of the package.The procedure was completed with another encore 26 inflation device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a020503 captures the reportable event of seal compromised.Block h10: investigation results: the returned encore 26 inflation device was analyzed, and a visual examination found that the gauge needle was at 0 atm when received and the device packaging pouch was found torn.A media inspection was performed on the photos provided by the customer and shows that the device packaging pouch was not sealed correctly in one photo.In the other photo, the packaging cover/paper was peeled back during opening, but the paper remained intact around portions of the seal.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of packaging seal compromised was confirmed.During product analysis it was observed that the device packaging pouch was torn.This could be related to a manufacturing deficiency event because the customer encountered complications at the moment of opening the device to perform the procedure.This confirms that a deficiency on the manufacturing process occurred prior to the delivery of the device to the customer, contributing to the observed damage on the pouch.Therefore, the most probable root cause is a manufacturing deficiency.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/product label.

• Brand Name: ENCORE 26
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18103631
• MDR Text Key: 328966357
• Report Number: 3005099803-2023-06097
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729755241
• UDI-Public: 08714729755241
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K955869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

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 Model Number: M00566670
• Device Catalogue Number: 6667
• Device Lot Number: 0031508675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 12/14/2023
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2023
• 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