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

Model Number M00542421

Device Problem Optical Problem (3001)

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

Event Date 03/08/2022

Event Type  malfunction  

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 90 minutes of use.The exalt controller was restarted multiple times but visualization could not be restored.The physician switched to a reusable 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 exalt model d single use duodenoscope 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 and no articulation nor 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 scope was visualized under x-ray at the umbilicus connector and distal tip.No issues with the device umbilicus or conductors near the distal tip were observed.The top of the device handle was opened to inspect the repeater button printed circuit board assembly (pcba).Evidence of procedural fluid ingress in the form of corrosion and crystalline residue was observed on both sides of the pcba, and in the screw holes within the handle.The bottom of the device handle was opened and fluid as well as additional residue and corrosion were observed on the elevator control assembly and beneath the articulation control knobs.Air/water (a/w) and suction valve buttons and a biopsy valve were attached to the exalt scope.A 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 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.During these tests, no leakage into the device handle was observed.Disassembly of the device at the distal end was initiated to determine if procedural fluid residue was also present in this region of the device.Upon attempting to cut off the articulation joint (aj) cover, it was observed to have detached from the entire circumference of the distal tip.It was observed that adhesive remained on both the distal cap and the aj cover, and no tears in the aj cover were noted.The distal tip was removed from the articulation joint and pulled out of the insertion tube slightly.The working channel, fluidics tubing, and elevator control wire were cut just proximal to the distal tip and removed from the insertion tube by pulling them proximally through the handle.Crystalline residue was observed on the coil pipe which the elevator control wire runs through.Additionally, fluid was observed in the elevator control wire liner from the distal end to the proximal end.It appeared as if fluid entered the handle by traveling up the insertion tube components during the procedure.A drop of saline was placed on the repeater button pcba and image was lost.The reported event was confirmed.Therefore, based on the investigation findings, the probable cause for the reported event was determined to be cause traced to component failure, which indicates that the failure mode is attributable to random or expected component failure, specifically of the glue feature between the aj cover and distal tip.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.

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 90 minutes of use.The exalt controller was restarted multiple times but visualization could not be restored.The physician switched to a reusable scope and completed the procedure.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: 13995053
• MDR Text Key: 288489617
• Report Number: 3005099803-2022-01742
• 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: 05/16/2022

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 Expiration Date: 07/27/2023
• Device Model Number: M00542421
• Device Catalogue Number: 42421
• Device Lot Number: 0027737674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 04/21/2022
• Supplement Dates FDA Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2021
• 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