MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXALT CONTROLLER; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M00542430

Device Problem Optical Problem (3001)

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

Event Date 11/13/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number for the exalt model d scope 3005099803-2023-06663 and for the exalt model d controller 3005099803-2023-07083.It was reported to boston scientific corporation that an exalt model d scope was used on an endoscopic retrograde cholangiopancreatography (ercp) used to treat stones in the bile duct performed on (b)(6) 2023.During the procedure, visualization was lost.The procedure was able to be finished using the original device however, it had to be restarted multiple times.There have been no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.Block h10: with all available information, the investigation found the loss of visualization is unlikely related to manufacturing, as product analysis identified issues related to use and maintenance and did not identify any manufacturing defect.Although the number of procedures/recycles of the unit are unknown, improper handling of the device or wear/tear on internal components over time likely contributed to the event.There were no manufacturing deviations noted.A risk review confirmed that loss of visualization is accounted for with the device risk documentation.The returned exalt model d controller was visually inspected.The top cover and front panel had damage to the finish and the rear bumper was cracked.It was also revealed that the catheter contacts were contaminated with an unknown material preventing a consistent video.These contacts could not be cleaned sufficiently and will require replacement to restore a stable video.According to these findings, the complaint was confirmed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.With all the available information, boston scientific concludes that the root cause of this event is traced to maintenance, which indicates that problems are traced to improper routine or preventative maintenance.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number for the exalt model d scope 3005099803-2023-06663 and for the exalt model d controller 3005099803-2023-07083.It was reported to boston scientific corporation that an exalt model d scope was used on an endoscopic retrograde cholangiopancreatography (ercp) used to treat stones in the bile duct performed on (b)(6) 2023.During the procedure, visualization was lost.The procedure was able to be finished using the original device however, it had to be restarted multiple times.There have been no patient complications reported as a result of this event.

• Brand Name: EXALT CONTROLLER
• Type of Device: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): ENERCON TECHNOLOGIES; 25 northbrook dr; 665; gray ME 04039
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18466417
• MDR Text Key: 332911692
• Report Number: 3005099803-2023-07083
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 08714729990901
• UDI-Public: 08714729990901
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K193202
• 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: 04/04/2024

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: M00542430
• Device Catalogue Number: 4243
• Device Lot Number: 2005201220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1