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

Model Number M00566670

Device Problems Device Contamination with Chemical or Other Material (2944); Physical Resistance/Sticking (4012)

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

Event Date 06/15/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that an encore 26 inflation device was used during a dilation of bronchi procedure performed on (b)(6) 2021.During unpacking, a fluid was noticed inside the pumping catheter of the device.Additionally, the handle was not working smoothly and there was resistance felt during the handle movement.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 e1: initial reporter phone: (b)(6) block h6: device code a180104 captures the reportable issue of foreign material present on the device.Block h10: investigation result a visual examination of the returned complaint device found an excess of silicone in the flexcil line of the device.Functional analysis were performed; pressure damping test, vacuum test, gauge accuracy test, side load test, device locking mechanism test and the device passed all the test without problem.An investigation into the reported problem was conducted and identified that the foreign material present in the device has been determined to be a cosmetic issue only as it was found that it was not a foreign material but a silicone which is applied to the encore barrel during manufacturing process and has been considered through biocompatibility assessments.The purpose of the silicone is to lubricate the transition of the barrel onto the plunger and prevent the plunger o-ring being dragged out of position which could have affect the device functionality.This failure is likely due to problems traced to design/design features of the device that do not support or interfere with the intended purpose of the device.Therefore, the most probable root cause is design inadequate for purpose.An investigation to address this issue has been completed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.

Event Description

It was reported to boston scientific corporation that an encore 26 inflation device was used during a dilation of bronchi procedure performed on (b)(6), 2021.During unpacking, a fluid was noticed inside the pumping catheter of the device.Additionally, the handle was not working smoothly and there was resistance felt during the handle movement.The procedure was completed with another encore 26 inflation device.There were no patient complications reported as a result of this event.

• Brand Name: ENCORE 26
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12148082
• MDR Text Key: 260956178
• Report Number: 3005099803-2021-03302
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729755241
• UDI-Public: 08714729755241
• 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
• Type of Report: Initial,Followup
• Report Date: 10/04/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2024
• Device Model Number: M00566670
• Device Catalogue Number: 6667
• Device Lot Number: 0026993536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 07/10/2021
• Supplement Dates Manufacturer Received: 09/09/2021
• Supplement Dates FDA Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1