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

Model Number 42421

Device Problem Optical Problem (3001)

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

Event Date 09/16/2021

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) 2021.As the physician was removing the scope from the patient at the end of the procedure, the screen went black and the scope error screen appeared.The physician unhooked the umbilicus and reconnected it, visualization recovered briefly and then went black.After trying this several times, the physician extracted the scope from the patient as the procedure had been completed with no complications.

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) 2021.As the physician was removing the scope from the patient at the end of the procedure, the screen went black and the scope error screen appeared.The physician unhooked the umbilicus and reconnected it, visualization recovered briefly and then went black.After trying this several times, the physician extracted the scope from the patient as the procedure had been completed with no complications.

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.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 relief at the connector and the handle; no issues were observed with the image.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 directions for use (dfu) / 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: 12610117
• MDR Text Key: 275875965
• Report Number: 3005099803-2021-05024
• 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: 11/05/2021

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: 01/18/2023
• Device Model Number: 42421
• Device Catalogue Number: 42421
• Device Lot Number: 0026652726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2021
• Initial Date FDA Received: 10/11/2021
• Supplement Dates Manufacturer Received: 10/12/2021
• Supplement Dates FDA Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2021
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Race: White