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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXALT MODEL D SINGLE-USE DUODENOSCOPE; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
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BOSTON SCIENTIFIC CORPORATION EXALT MODEL D SINGLE-USE DUODENOSCOPE; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number M0054242CE0
Device Problem Optical Problem (3001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/19/2021
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 cholangiopancreatography (ercp) procedure performed in the duodenum on (b)(6) 2021.During the procedure, the image was lost while the exalt scope was in front of the papilla.The transition screen appeared, followed by the loading screen which displayed gray dots.It was reported that a sphincterotome and guidewire were being used when the image was lost.The procedure was completed with a non-bsc, reusable 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 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.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 tip was manually manipulated and no problems were observed with the image.The umbilicus connector was manipulated by applying rotational pressure and no problems were observed with the image.The length of the catheter was manually manipulated, and tension was applied to the strain relief locations in the umbilicus cable (near the handle and near the umbilicus connector).No impact to the image was observed.The handle was opened to visually inspect the interposer connectors and electronics.The interposers were fully seated in position, and had no adhesive wicking into the connectors.X-ray imaging of the tip and umbilicus connector showed no problems with electronic components.The reported event was not confirmed.Product analysis was unable to replicate the reported event or identify any problem that could have caused or contributed to the reported event.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 cholangiopancreatography (ercp) procedure performed in the duodenum on (b)(6) 2021.During the procedure, the image was lost while the exalt scope was in front of the papilla.The transition screen appeared, followed by the loading screen which displayed gray dots.It was reported that a sphincterotome and guidewire were being used when the image was lost.The procedure was completed with a non-bsc, reusable duodenoscope.There were no patient complications reported as a result of this event.
 
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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 Key11914622
MDR Text Key253562057
Report Number3005099803-2021-02519
Device Sequence Number1
Product Code FDT
UDI-Device Identifier08714729995746
UDI-Public08714729995746
Combination Product (y/n)N
PMA/PMN Number
K193202
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/09/2022
Device Model NumberM0054242CE0
Device Catalogue Number4242CE
Device Lot Number0026157789
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2021
Date Manufacturer Received07/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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