MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXALT MODEL D SINGLE-USE DUODENOSCOPE; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M0054242CE1

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)

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

Event Date 12/08/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that an exalt model d single-use duodenoscope was introduced for use in an endoscopic retrograde cholangiopancreatography (ercp) on (b)(6) 2022.During the procedure, the patient was placed under local anesthesia.The scope was inserted into the patient when visualization was lost and the scope error screen appeared.The scope was removed from the patient and a second exalt model d scope was inserted into the patient.Visualization was lost inside the patient again.The procedure was discontinued and rescheduled.There were no patient complications as a result of this event.This report pertains to one of two devices used with the same patient.Refer to manufacturer report # 3005099803-2022-07484 for the associated device information.

Manufacturer Narrative

Block h6: device code a06 captures the reportable event of loss of visualization inside the patient.H10 device analysis: with all the available information, boston scientific concludes that the reported loss of visualization is confirmed, as the product analysis identified that the device 12 pin interposer was improperly seated in the umbilicus connector, leading to the loss of visualization and scope error screen.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Upon receipt of this scope at our quality assurance laboratory, this device was thoroughly analyzed.Visual examination of the scope did not identify any damage or defect on the shaft or tip of the device.There was no fogging or condensation on the lens.Witness marks were observed on the pads of the umbilicus connector, indicating that the device had been connected to a controller.An image assessment was performed by connecting the device to an exalt controller.Upon connection, the image displayed for a moment, but the light emitting diode (led) did not turn on; therefore, the scope error screen displayed.The scope was unplugged and re-plugged in and the led was turned off from the controller; the live image remained on with the led turned off.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 without led.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 visualized under real-time x-ray imaging, and it was observed that the 12-pin interposer was crooked and not fully seated in the umbilicus pcba connector.The umbilicus connector was opened, and the 12-pin interposer connection was inspected.The interposer was easily removed from the connector, as the glue feature was no longer adhered to the underside of the flex strip.The adhesive remained bonded to the connector on the umbilicus pcba.The 12-pin interposer was re-seated into the connector, the umbilicus connector was closed, and the scope was plugged into the controller and a live, clear image with led was displayed, resolving the image issues.There was no evidence that the device was not properly assembled, and manufacturing tests verify image throughout the manufacturing process.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Based on all the available information, boston scientific's complaint investigation determined the most probable cause of this event was due to an expected or random component failure without any evidence of a design or manufacturing-related cause.An investigation to address this problem is in progress.

Event Description

It was reported to boston scientific corporation that an exalt model d single-use duodenoscope was introduced for use in an endoscopic retrograde cholangiopancreatography (ercp) on (b)(6) 2022.During the procedure, the patient was placed under local anesthesia.The scope was inserted into the patient when visualization was lost and the scope error screen appeared.The scope was removed from the patient and a second exalt model d scope was inserted into the patient.Visualization was lost inside the patient again.The procedure was discontinued and rescheduled.There were no patient complications as a result of this event.Note: this report pertains to one of two devices used with the same patient.Refer to manufacturer report # 3005099803-2022-07476/3005099803-2022-07484 for the associated device information.

• Brand Name: EXALT MODEL D SINGLE-USE DUODENOSCOPE
• Type of Device: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/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: 16005027
• MDR Text Key: 308167601
• Report Number: 3005099803-2022-07476
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 08714729995753
• UDI-Public: 08714729995753
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 03/21/2023

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: M0054242CE1
• Device Catalogue Number: 4242CE
• Device Lot Number: 0030375976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 03/10/2023
• Supplement Dates FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2022
• 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