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

Model Number M0054242CE1

Device Problems Mechanical Jam (2983); Appropriate Term/Code Not Available (3191)

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

Event Date 12/15/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).(report source): (b)(4) exalt dscope 02 clinical study.(b)(4).The device has not been received for analysis.Upon receipt and 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

A (b)(6)-year-old male patient (b)(6), enrolled in the exalt dscope 02 study, underwent an endoscopic retrograde cholangiopancreatography (ercp) on (b)(6) 2021.During the procedure, the physician experienced technical failure of the exalt model d scope due to issues with the scope's elevator.The procedure was not completed.The principal investigator reported this event as a device deficiency.There were no serious adverse events reported.No further information has been obtained despite good faith efforts.

Event Description

A 51-year-old male patient (b)(6), enrolled in the exalt dscope 02 study, underwent an endoscopic retrograde cholangiopancreatography (ercp) on (b)(6) 2021.During the procedure, the physician experienced technical failure of the exalt model d scope due to issues with the scope's elevator.The procedure was not completed.The principal investigator reported this event as a device deficiency.There were no serious adverse events reported.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block e1 initial reporter address: (b)(6) block g2 (report source): e7156 exalt dscope 02 clinical study block h6 (impact code): impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.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 damage to the device handle was observed.The tip of the device was visually analyzed and no issues were observed with the camera lens or in the area around the elevator and working channel.The scope umbilicus connector was plugged into a controller and a clear, live image displayed.Using the knobs on the handle, the scope was articulated in all directions and combinations of directions.No image or articulation issues were observed.The elevator was actuated using the lever on the handle.The elevator at the distal tip was actuated as expected.This testing was repeated with the scope in a straight and looped orientation; no problems were detected.A spyscope ds scope was passed through the working channel of the exalt d scope until it emerged several centimeters from the distal tip.The elevator was actuated to lift the spyscope with the scope in both straight and looped configurations; no issues were identified with the elevator and no latency between actuating the lever and movement of the elevator was observed.The reported complaint was not confirmed as analysis of the returned device could not replicate the reported elevator issues.Based on all gathered information, the cause for the reported complaint cannot be narrowed to one probable cause.Therefore, the chosen investigation conclusion code for this complaint is no problem detected, which indicates that no issues with the returned device or product records were identified which could have caused or 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 labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.Block h11: block h6 (impact codes) has been corrected.

• 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: 13232960
• MDR Text Key: 283682958
• Report Number: 3005099803-2021-08223
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 08714729995753
• UDI-Public: 08714729995753
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K193202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2023
• Device Model Number: M0054242CE1
• Device Catalogue Number: 4242CE
• Device Lot Number: 0027639383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2021
• 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: 51 YR
• Patient Sex: Male