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

Model Number M0054242CE1

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Appropriate Term/Code Not Available (3191)

Patient Problem Swelling/ Edema (4577)

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(report source): e7158 exalt d scope 01b 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

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) 2021 as part of the exalt d scope 01b clinical study.The patient had a medical history of native major papilla, previous ercps, and a prior stent placement.During the procedure, the exalt scope had poor visibility due to continuous water flow over the lens during insufflation.It was reported that the ercp could not be completed due to failed cannulation of the pancreatic duct.Additionally, the physician chose not to complete the procedure with a reusable scope due to the patient's duodenal edema.There was no reported treatment required for the edema.Cannulation was successful during a follow up ercp procedure that was performed on (b)(6) 2021.There were no additional patient complications reported as a result of this event.

Manufacturer Narrative

Block e1 (initial reporter facility name): (b)(6).Block g2 (report source): e7158 exalt dscope 01b clinical study.Block h6 (device codes): problem code a27 captures the reportable event of aborted/cancelled procedure.Block h6 (evaluation conclusion codes): evaluation conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: 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 cholangiopancreatography (ercp) procedure performed in the duodenum on february 4, 2021 as part of the exalt d scope 01b clinical study.The patient had a medical history of native major papilla, previous ercps, and a prior stent placement.During the procedure, the exalt scope had poor visibility due to continuous water flow over the lens during insufflation.It was reported that the ercp could not be completed due to failed cannulation of the pancreatic duct.Additionally, the physician chose not to complete the procedure with a reusable scope due to the patient's duodenal edema.There was no reported treatment required for the edema.Cannulation was successful during a follow up ercp procedure that was performed on february 24, 2021.There were no additional patient complications reported as a result of this event.Additional information received on march 10, 2021.The patient also had a medical history of chronic pancreatitis.According to the principal investigator, the cause of the patient's duodenal edema was ongoing pancreatitis.There was no specific treatment for the duodenal edema.

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) 2021 as part of the exalt d scope 01b clinical study.The patient had a medical history of native major papilla, previous ercps, and a prior stent placement.During the procedure, the exalt scope had poor visibility due to continuous water flow over the lens during insufflation.It was reported that the ercp could not be completed due to failed cannulation of the pancreatic duct.Additionally, the physician chose not to complete the procedure with a reusable scope due to the patient's duodenal edema.There was no reported treatment required for the edema.Cannulation was successful during a follow up ercp procedure that was performed on (b)(6) 2021.There were no additional patient complications reported as a result of this event.***additional information received on (b)(6) 2021*** the patient also had a medical history of chronic pancreatitis.According to the principal investigator, the cause of the patient's duodenal edema was ongoing pancreatitis.There was no specific treatment for the duodenal edema.

Manufacturer Narrative

Block e1 (initial reporter facility name): (b)(6) block g2 (report source): e7158 exalt dscope 01b clinical study block h6 (device codes): problem code a27 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 (a/w) 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 was not consistent with the specifications given in the valve body drawing.Orca 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 a/w 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 tested 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.The orca a/w button was rotated within the valve body port in exalt until it was in a raised position.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.The button was released and water stopped flowing from the tip.Insufflation was tested by covering the air port of the a/w button.Water was observed flowing from the tip during insufflation (unintended irrigation).This test was repeated five times, and the unintended irrigation did not happen again after the second cycle of air/water.Analysis of the returned device confirmed that a leak in the orca air/water button due to difficulty seating the buttons results in unintended irrigation during insufflation.The reported event was confirmed, as unintended irrigation of water was observed at the tip during insufflation testing.It is likely that the collar dimension being out of specification could contribute to the observed leak by making the proper seating of the orca button more difficult.Based on all available information, the conclusion code selected for the event is cause traced to device design.An investigation to address this problem is in progress.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.

• 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: 11419207
• MDR Text Key: 234955224
• Report Number: 3005099803-2021-00668
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 08714729995753
• UDI-Public: 08714729995753
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2021

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: 03/12/2021
• Device Model Number: M0054242CE1
• Device Catalogue Number: 4242CE
• Device Lot Number: 0025350069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Initial Date Manufacturer Received: 02/06/2021
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 03/10/2021; 05/12/2021
• Supplement Dates FDA Received: 04/07/2021; 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR