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

Model Number M0054242CE1

Device Problems Poor Quality Image (1408); Appropriate Term/Code Not Available (3191)

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

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

(report source): e7158 exalt dscope 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.During the procedure, the physician attempted to cannulate with the exalt scope six times and was unsuccessful.The physician stated that there was a blurred image.Therefore, the physician switched out the exalt scope for a non-bsc reusable scope.The physician attempted to cannulate six times with the reusable scope but was still unsuccessful.A precut-sphincterotomy was performed with the reusable scope; however, the physician was still unable to cannulate the common bile duct.A duodenal probe was inserted and then the procedure was aborted.The physician was able to cannulate the common bile duct in a follow up ercp procedure that was performed six days later.There were no patient complications reported as a result of this event.

Manufacturer Narrative

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.No fluid or condensation was observed on or under the camera lens.An image test was performed by plugging the exalt umbilicus into a controller.A clear, live image was displayed, no image problems were identified.The device was fully articulation in all directions, and the umbilicus connector was wiggled in the controller; no image degradation was observed.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.The scope image was tested during irrigation and insufflation 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 with irrigation or the image were observed.Insufflation was tested by covering the air port of the orca.No problems with insufflation or the image was observed.This test was repeated five times and no problems were noted.The reported event was not confirmed.Functional testing of the returned device did not detect visibility problems.Based on all gathered information, the conclusion code selected for the reported complaint 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 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 cholangiopancreatography (ercp) procedure performed in the duodenum on (b)(6), 2021 as part of the exalt d scope 01b clinical study.During the procedure, the physician attempted to cannulate with the exalt scope six times and was unsuccessful.The physician stated that there was a blurred image.Therefore, the physician switched out the exalt scope for a non-bsc reusable scope.The physician attempted to cannulate six times with the reusable scope but was still unsuccessful.A precut-sphincterotomy was performed with the reusable scope; however, the physician was still unable to cannulate the common bile duct.A duodenal probe was inserted and then the procedure was aborted.The physician was able to cannulate the common bile duct in a follow up ercp procedure that was performed six days later.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: 11401830
• MDR Text Key: 234368228
• Report Number: 3005099803-2021-00529
• 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
• Report Date: 06/17/2021

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: 08/20/2022
• Device Model Number: M0054242CE1
• Device Catalogue Number: 4242CE
• Device Lot Number: 0025890990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 05/24/2021
• Supplement Dates FDA Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR