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

Model Number M00542420

Device Problem Optical Problem (3001)

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

Event Date 04/19/2022

Event Type  malfunction  

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 performed on (b)(6) 2022.During the procedure, the exalt model d scope lost visualization after 45 minutes of use as the physician was attempting a biopsy in the patient's common bile duct.The physician switched to another exalt model d scope and completed the procedure.There were no patient complications as a result of this event.

Manufacturer Narrative

(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

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 performed on (b)(6), 2022.During the procedure, the exalt model d scope lost visualization after 45 minutes of use as the physician was attempting a biopsy in the patient's common bile duct.The physician switched to another exalt model d scope and completed the procedure.There were no patient complications 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: 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.No issues with the device handle were noted.No damage to the umbilicus cable, connector, or its ports were observed.An image assessment was performed by connecting the device to an exalt controller; a live, clear image was displayed.The scope was articulated in all directions; no articulation or image issues were observed.The scope umbilicus was manipulated at the strain relief locations near the handle and at the umbilicus connector.No image issues nor issues with the physical connection between the scope and controller were observed.The top of the device handle was opened to inspect the repeater button printer circuit board assembly (pcba).Evidence of procedural fluid ingress in the form of corrosion was observed on both sides of the pcba.The bottom of the device handle was opened and additional signs of fluid ingress in the form of residue and corrosion were observed on the elevator control assembly.The umbilicus connector was opened and visually inspected; no signs of damage or fluid ingress was noted.Fluidics testing was performed to identify potential leaks into the handle.Orca air/water (a/w) and suction valve buttons and a seal biopsy valve were attached to the exalt scope.A hydra water bottle cap was connected to a water bottle filled with water and compressed air at approximately 7 pounds per square inch (psi) was connected to the hydra tubing.Insufflation, irrigation, and suction were tested by cycling each 3 times: for insufflation, the air port of the a/w button was covered and air flowed out of the tip of the device; for irrigation, the a/w button was depressed and water flowed out of the tip of the device; for suction, the tip was submerged in a beaker of water and the suction button was depressed.No fluidics issues were identified, and no device leakage was observed during these tests.The device was further leak tested by sealing the distal tip in a tube and performing irrigation with the hydra and orca setup described.The handle was open to observe potential leak paths.The air/water button was pressed to allow water to flow through the scope and fill the tube sealed onto the distal tip.Within 20 to 30 seconds of irrigating, water was observed flowing out of the proximal end of the insertion tube and into the handle.The distal tip was disconnected from the articulation joint and slightly pulled out of the distal end of the insertion tube to visualize the proximal side of the distal tip.The distal tip was again sealed into the tube and irrigation was performed.Water was observed leaking through the cutout for the camera assembly at the proximal side of the distal tip.A drop of saline was placed on the repeater button pcba at the j5 and j6 components, where corrosion was observed, and image was lost; the monitor displayed the 5-dot initialization screen prior to the exalt splash screen.During returned product analysis, evidence of procedural fluid ingress into the handle was observed, including on electrical components of the pcba in the scope handle.Contacting the affected locations with saline resulted in a loss of image.Attempts to identify a leak path during analysis revealed no issues with the fluidics system.Leak testing revealed that, in a pressurized system, fluid could leak through the distal tip and into the insertion tube, through cutouts designed for assembling components into the distal tip.No device defects were identified which could have contributed to the leakage.According to the event description, the device was used for 45 minutes; analysis was able to replicate fluid flow up the insertion tube and into the handle within 30 seconds of irrigating.It is possible that procedural factors during use pressurized the device for long enough to result in the backflow of procedural fluid into the handle.The handle may have filled with enough fluid to contact the electrical components and disrupt the image, or the user may have tilted the handle of the device flat, allowing fluid contact with the electronics.Based on all gathered information, the probable cause for the reported event was determined to be adverse event related to procedure, which indicates that the event was attributed to procedural factors, and the device had no influence on its occurrence.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: 14408861
• MDR Text Key: 291747356
• Report Number: 3005099803-2022-02731
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 08714729983514
• UDI-Public: 08714729983514
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2023
• Device Model Number: M00542420
• Device Catalogue Number: 42420
• Device Lot Number: 0028187674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2021
• 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 Age: 78 YR
• Patient Sex: Male
• Patient Weight: 63 KG