MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXALT MODEL D SINGLE-USE DUODENOSCOPE; DUODENOSCOPE (FLEXIBLE OR RIGID)

Model Number M0054242

Device Problem Optical Problem (3001)

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

Event Date 11/16/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an exalt model d single-use duodenoscope, was used in an endoscopic retrograde cholangiopancreatography (ercp) to treat common bile duct (cbd) stones on (b)(6) 2022.Once the scope was positioned to attempt cannulation, the scopes visualization was lost and could not be regained.The physician then removed the scope from the patient.The procedure was able to be completed with another exalt scope.There were no reported patient complications as result of this event.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.Block h10: the returned device was visually inspected.No evidence of any damage or defect was observed on the shaft or tip of the device.No fogging or condensation was noted on or in the lens.Witness marks were observed on the pads of the umbilicus connector, indicating it was connected to a controller.An image assessment was performed by connecting the device to an exalt controller.Upon connection, a live, clear image was displayed.Articulation of the tip was performed using the control knobs on the handle, the tip was manually manipulated, and the umbilicus cable and connector were manipulated by rotating the connector at the controller, applying tension to the cable, and stressing the strain reliefs at the connector and the handle, no issues with the image were observed.The handle was opened to visually inspect the repeater button printed circuit board assembly (pcba) at the top of the handle, and the grounding components in the bottom of the handle.No visual defects were identified.The umbilicus connector was opened and it was observed that the 12-pin interposer was crooked at its connection to the umbilicus pcba.The glue feature was also no longer adhered to the underside of the flex strip, and the interposer could be wiggled side to side.A calibrated multimeter was used to test continuity of the umbilicus.It was found that, when probing the umbilicus pogo pads, the umbilicus signals were disrupted when wiggling the interposer.This was tested on the light emitting diode (led) signal by probing pads 1 and 2, ground to serial data (sda) by probing pads 7 and 15, ground to serial clock (scl) by probing pads 7 and 16, and power to ground by probing pads 3 and 7.The reported event was confirmed.Therefore, based on the investigation findings, the 12-pin interposer was not properly seated in the umbilicus pcba connector, and signals from the umbilicus were disrupted when wiggling the interposer, as tested with a calibrated multimeter.It is possible that an intermittent issue related to this improper connection contributed to the image issues observed by the user.There was no evidence that the device was not properly assembled, and manufacturing tests verify image throughout the process.It is possible that the connection was disrupted due to handling in the manufacturing process, shipping, or the attempt to use the device, however, a more specific cause could not be determined.Therefore, the probable cause of the reported event was determined to be cause traced to component failure, which indicates that the issues could be traced to an expected or random failure of a component with no detected element of design or manufacturing.A search of the complaint database found one additional complaint related to loss of visualization against this batch was identified since manufacturing in january 2021, pending investigation.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) or product label.

Event Description

It was reported to boston scientific corporation that an exalt model d single-use duodenoscope, was used in an endoscopic retrograde cholangiopancreatography (ercp) to treat common bile duct (cbd) stones on (b)(6) 2022.Once the scope was positioned to attempt cannulation, the scopes visualization was lost and could not be regained.The physician then removed the scope from the patient.The procedure was able to be completed with another exalt scope.There were no reported patient complications as result of this event.

• Brand Name: EXALT MODEL D SINGLE-USE DUODENOSCOPE
• Type of Device: DUODENOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15976164
• MDR Text Key: 308147748
• Report Number: 3005099803-2022-07366
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 08714729993605
• UDI-Public: 08714729993605
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0054242
• Device Catalogue Number: 42421
• Device Lot Number: 0030367498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2022
• 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
• Patient Sex: Male