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

Model Number M00542421

Device Problems Infusion or Flow Problem (2964); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

(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

It was reported to boston scientific corporation that an exalt model d single-use duodenoscope was used during an endoscopic retrograde cholangioapancreatography (ercp) procedure performed in the common bile duct on (b)(6) 2020.According to the complainant, during the procedure, the exalt scope was used with non-bsc reusable carbon dioxide tubing.The exalt scope experienced insufflation issues with this tubing.The physician switched to a non-bsc reusable scope; however, cannulation could not be completed with the reusable scope.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 (device codes): problem code 3191 captures the reportable event of aborted/cancelled procedure.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 or defect on the shaft or tip of the device.Both the air/water valve port and suction valve port were visually inspected and no problems were observed.The tip of the device was visually analyzed and no problems were observed in the area around the water/insufflation ports.The collar on the exalt was measured using calipers and compared to the valve body drawing.The collar measurement on the returned unit met the specifications noted in the valve body drawing.Orca air/water (a/w) and suction buttons were installed into the valve ports on the exalt device and no problems were observed.The collars of the buttons were fully pressed against the exalt handle.Irrigation and insufflation was functionally tested by attaching a water bottle to a hydra water bottle cap and using the hydra water bottle cap to connect to the exalt umbilicus air/water port.Compressed air was connected to the hydra.The orca button was depressed to test water function, and a flow of water was observed at the tip of the exalt device.No problems were observed.Insufflation was testing by covering the air port of the orca.Air was observed flowing at the tip of the exalt device.No problems were observed.This test was repeated five times and no problems were noted.No other problems with the device were noted.The reported event was not confirmed.Product analysis was unable to replicate or identify any problem that could have caused or contributed to the reported event.It is likely that the problem was caused by the tubing since it was a common component between the complaint device and the reusable scope used.Based on all gathered information, the conclusion code selected for this event is no problem detected.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.

Event Description

It was reported to boston scientific corporation that an exalt model d single-use duodenoscope was used during an endoscopic retrograde cholangioapancreatography (ercp) procedure performed in the common bile duct on (b)(6), 2020.According to the complainant, during the procedure, the exalt scope was used with non-bsc reusable carbon dioxide tubing.The exalt scope experienced insufflation issues with this tubing.The physician switched to a non-bsc reusable scope; however, cannulation could not be completed with the reusable scope.The procedure was not completed due to this event.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: 11066110
• MDR Text Key: 223452381
• Report Number: 3005099803-2020-06382
• 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: 01/22/2021

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: 09/23/2022
• Device Model Number: M00542421
• Device Catalogue Number: 42421
• Device Lot Number: 0026067180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1