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 07/06/2021

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.During the procedure, the scope error screen appeared.Rebooting and re-inserting the exalt model d single-use duodenoscope did not clear the error message.This procedure was successfully completed with a second exalt model d single-use duodenoscope.There were no patient complications reported 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 exalt model d single-use duodenoscope was received for analysis.There was no visual evidence of any damage or defect on the shaft or tip of the device.No fogging or condensation was noted on or in the lens.No damage to the umbilicus connector was identified; witness marks were observed to be centered on the contacts of the connector.An image assessment was performed by connecting the device to an exalt controller.Upon connection, a live image was displayed.No problems were observed with the image.Articulation of the scope was performed using the control knobs on the handle.The scope led turned off when the tip was fully articulated in the up and right directions simultaneously, leading to the scope error screen after several seconds.The unit was disconnected, the tip was straightened, and the device was reconnected to the controller; a live image was displayed again until the scope was articulated into the fully up and right position.The image and articulation test was repeated with the led turned off from the controller.No image problems were identified with the led turned off.The handle of the device was opened.No damage to the printed circuit board assembly (pcba) or interposers were observed; the interposers were observed to be straight and fully seated in the connector.X-ray inspection of the wiring in the distal tip was performed, both with the tip in a straight orientation and with the tip articulated such that the error screen displayed.With the tip articulated, potential damage to the led wire braid was observed located within the distal cap, inaccessible to dissection and visual inspection.Electrical testing of the device was performed using a multimeter.The led cathode was discontinuous when the tip was articulated into the up and right position, confirming the reported event.Therefore the conclusion code selected for this event is cause traced to component failure.No additional complaints for this batch were identified since manufacturing in november 2020.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 d9 (return to manufacturer date) has been corrected.

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.During the procedure, the scope error screen appeared.Rebooting and re-inserting the exalt model d single-use duodenoscope did not clear the error message.This procedure was successfully completed with a second exalt model d single-use duodenoscope.There were no patient complications reported 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
• MDR Report Key: 12231168
• MDR Text Key: 263857499
• Report Number: 3005099803-2021-03807
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 08714729993605
• UDI-Public: 08714729993605
• Combination Product (y/n): N
• PMA/PMN Number: K193202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

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: 11/06/2022
• Device Model Number: M00542421
• Device Catalogue Number: 42421
• Device Lot Number: 0026318006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Initial Date Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 07/27/2021
• Supplement Dates Manufacturer Received: 08/19/2021
• Supplement Dates FDA Received: 09/09/2021
• Patient Sequence Number: 1