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

Model Number M0054242CE1

Device Problem Optical Problem (3001)

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

Event Date 12/08/2022

Event Type  malfunction  

Event Description

Note: this report pertains to one of two devices used with the same patient.Refer to manufacturer report # 3005099803-2022-07476 for the associated device information.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.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Block h6: device code a06 captures the reportable event of loss of visualization inside the patient.Block h10: upon receipt of this scope at our quality assurance laboratory, this device was thoroughly analyzed.Visual examination did not identify 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 image was displayed.No issues were observed with the image.Articulation of the tip was performed using the control knobs on the handle, and no changes to the image quality were observed.The tip was manually manipulated, and no issues were observed with the image.The umbilicus was 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 were observed with the image.The handle was opened to visually inspect the repeated button printed circuit board (pcba) at the top of the handle, and the grounding components in the bottom of the handle.No visual defects were identified.A review of the photo provided by the account was performed.The photo depicted the "scope error screen", which indicates that there was a scope error during use.The reported loss of visualization was confirmed, based on media evidence provided by customer.However, a probable cause for the reported event cannot be established as the product analysis was unable to replicate the reported observation.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.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.

Event Description

Note: this report pertains to one of two devices used with the same patient.Refer to manufacturer report # 3005099803-2022-07476 for the associated device information.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.

• 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: 16005254
• MDR Text Key: 308387360
• Report Number: 3005099803-2022-07484
• 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: 02/07/2023

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: 01/17/2023
• Supplement Dates FDA Received: 02/07/2023
• 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