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 07/24/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(6) 2023.Block h6: device code a06 captures the reportable event of loss of visualization inside the patient.

Event Description

It was reported to boston scientific corporation that an exalt model d single-use duodenoscope was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2023.During the procedure, while the scope was in the patient's esophagus, the image of the exalt model d scope was lost.The scope was unplugged and re-plugged with no result.Therefore, a second exalt model d scope was opened and used to complete the procedure.There were no patient complications as a result of this event.

Event Description

It was reported to boston scientific corporation that an exalt model d single-use duodenoscope was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2023.During the procedure, while the scope was in the patient's esophagus, the image of the exalt model d scope was lost.The scope was unplugged and re-plugged with no result.Therefore, a second exalt model d scope was opened and used to complete the procedure.There were no patient complications as a result of this event.

Manufacturer Narrative

Device code a06 captures the reportable event of loss of visualization inside the patient.The returned device was visually toughly inspected and analyzed.No evidence of any damage or defect was observed on the handle, umbilicus, shaft or tip of the device.No fogging or condensation was noted on or in the lens.Residue was noted on the umbilicus connector and internal component on the printed circuit board (pcba).An image assessment was performed by connecting the device to an exalt model d controller.Upon connection, a live, clear image displayed.However, once the umbilicus plug was released, the image was lost.The loading screen and boot screen were displayed.The umbilicus plug was manipulated at its connection with the controller and image could be obtained, but continued manipulation led to the same loading and boot screen sequence.The scope was unplugged and re-plugged into the controller and manipulated several times, resulting in loss of visualization, occasionally the scope error screen was displayed with this same manipulation.The scope was unplugged and plugged into a second exalt controller and a live, clear image displayed.The umbilicus plug was manipulated, and the loading was observed, then the live image returned.The scope error screen and boot screen were not observed in this second controller.The scope was unplugged from the controller and a calibrated digital multimeter in continuity mode was used to test the connections of the umbilicus board.The signals were confirmed to be within expected resistance of approximately 600 ohms.Additionally, the light-emitting diode (led) was confirmed to be continuous, and functional.Finally, it was confirmed that there was no short between power and ground.As residue was noted on the umbilicus connector and internal component on the printed circuit board (pcba), a 70% isopropyl alcohol (ipa) wipe was used to clean the internal components, which contact the controller pins to conduct necessary signals to operate the exalt single use device (sud).It was noted that residue was cleared off.Subsequently, the scope was plugged back into both controllers and similar manipulation of the umbilicus was performed, the image loss could no longer be replicated.It is likely that the residue observed on the umbilicus and internal components contributed to the reported event.The residue is suspected to be procedural, as visual inspections and in-process image tests would potentially identify residue during the manufacturing process.Therefore, based on all gathered evidence, the investigation conclusion code selected for the reported event is adverse event related to procedure, which indicates that factors external to the exalt model d scope likely contributed to the reported event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaints exist for the specified lot.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• 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: 17572177
• MDR Text Key: 321436566
• Report Number: 3005099803-2023-04447
• 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: 10/10/2023

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: 0031265893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 09/13/2023
• Supplement Dates FDA Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2023
• 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