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 Consequences Or Impact To Patient (2199)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

Report source: e7158 exalt dscope 01b clinical study.(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 in the duodenum on (b)(6) 2020 as part of the exalt d scope 01b clinical study.According to the complainant, during the procedure, the exalt scope lost visualization during esophageal insertion.The exalt scope was removed from the patient, and the procedure was completed with a reusable, non-bsc duodenoscope.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block g3: e7158 exalt dscope 01b clinical study block h6 (device codes): problem code 3001 captures the reportable event of loss of visualization inside the patient.Block h10: the returned exalt model d single-use duodenoscope was analyzed, and a visual evaluation noted that there was no evidence of any damage.No 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 problems 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 image was tested next during irrigation.Irrigation was performed by attaching a hydra water bottle cap to connect to the exalt umbilicus air/water port.Orca buttons were installed on the device in the valve ports.Compressed air was connected to the hydra water bottle cap.With a live image displayed on the controller and the device horizontally oriented on a table with the lens facing upwards, the orca button was depressed to allow water to flow through the device and out the tip over the lens.No problems were observed with the image quality throughout the fluidics test.No other problems with the device were noted.The reported event was not confirmed.A risk review was conducted to confirm that the reported event was anticipated in the documentation.A device history record (dhr) review confirms the device met all manufacturing specifications, and therefore it is unlikely that the issue was related to manufacturing.Product analysis was unable to replicate the failure or identify any problem that could have caused or contributed the reported event.The conclusion code selected for this is no problem detected, which indicates that the problem could not be confirmed.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.

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 in the duodenum on (b)(6), 2020 as part of the exalt d scope 01b clinical study.According to the complainant, during the procedure, the exalt scope lost visualization during esophageal insertion.The exalt scope was removed from the patient, and the procedure was completed with a reusable, non-bsc 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: 11065827
• MDR Text Key: 226302433
• Report Number: 3005099803-2020-06304
• 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: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2021
• Device Model Number: M00542421
• Device Catalogue Number: 42421
• Device Lot Number: 0025324017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR