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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
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BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number M00546600
Device Problems Material Protrusion/Extrusion (2979); Optical Problem (3001)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/07/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the common bile duct and intrahepatic bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the spyscope ds was inserted into the bile duct and observation was performed.In order to advance the device closer to the hepatic portal, the spyscope ds was articulated in all directions several times.The device was then inserted in the hepatic side and the physician continued observing the site thoroughly.However, during observation the physician noticed that the working channel sleeve protruded.Reportedly, working channel sleeve protrusion was prominent when the spyscope ds was articulated at a large angle.The working channel sleeve did not protrude when the spyscope ds was not articulated.With this information, the physician was able to perform biopsy inside the bile duct with minimum articulation.A spybite was inserted and used, and working channel sleeve protrusion was not noticed.However, when biopsy was performed in 2 or 3 more locations, working channel sleeve protrusion was noticed since articulation was required to reach those sites.It was also noticed that the image on the screen switched to gray with 5 dots on the screen, but the image eventually disappeared.It was suspected that the cord in the middle was disconnected due to articulation at a large angle.The image did not return after that, and since it happened towards the end of the procedure, they completed the procedure with the original spyscope digital access and delivery catheter.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the common bile duct and intrahepatic bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the spyscope ds was inserted into the bile duct and observation was performed.In order to advance the device closer to the hepatic portal, the spyscope ds was articulated in all directions several times.The device was then inserted in the hepatic side and the physician continued observing the site thoroughly.However, during observation the physician noticed that the working channel sleeve protruded.Reportedly, working channel sleeve protrusion was prominent when the spyscope ds was articulated at a large angle.The working channel sleeve did not protrude when the spyscope ds was not articulated.With this information, the physician was able to perform biopsy inside the bile duct with minimum articulation.A spybite was inserted and used, and working channel sleeve protrusion was not noticed.However, when biopsy was performed in 2 or 3 more locations, working channel sleeve protrusion was noticed since articulation was required to reach those sites.It was also noticed that the image on the screen switched to gray with 5 dots on the screen, but the image eventually disappeared.It was suspected that the cord in the middle was disconnected due to articulation at a large angle.The image did not return after that, and since it happened towards the end of the procedure, they completed the procedure with the original spyscope digital access and delivery catheter.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6 (device codes): the problem code 2979 captures the reportable event of working channel sleeve protrusion.Block h10: visual assessment was performed after disinfection.As received, the working channel sleeve (wcs) protruded.Maximum wcs protrusion was observed when the distal tip was articulated by turning the small and large knobs in the counterclockwise directions.The device was plugged into the controller.No image was displayed, confirming the reported complaint of loss of visualization.The distal tip was cut.The distal cap was removed.The catheter was cut open using the cutting fixture.The working channel sleeve was removed.Witness marks were noted on the pebax.The white areas along bond a appear to show evidence of adhesion.The complaint was consistent with the reported complaint incident of working channel sleeve protruding.Based on investigation results, the underlying cause of working channel sleeve protrusion is an insufficient bond, particularly the second heat cycle of the working channel sleeve bonding process [bond b].Working channel sleeve protrusion in devices manufactured post 01mar2018 changes has been determined to be a design issue, therefore, the complaint investigation conclusion code selected for the working channel sleeve protrusion issue is design inadequate for purpose, which indicates that problems were traced to design/design features of the device that do not support or do interfere with the intended purpose of the device.An investigation is underway to address this issue.A dhr (device history record) review was performed and did not identify evidence of deviations or non-conformances in the manufacturing processes that could contribute to the complaint.The dhr review confirms that the accepted device met all manufacturing specifications.
 
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Brand Name
SPYSCOPE DS
Type of Device
CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8203778
MDR Text Key131710284
Report Number3005099803-2018-62324
Device Sequence Number1
Product Code FBN
UDI-Device Identifier08714729863236
UDI-Public08714729863236
Combination Product (y/n)N
PMA/PMN Number
K142922
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/28/2019
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 Date09/11/2020
Device Model NumberM00546600
Device Catalogue Number4660
Device Lot Number0022643459
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/26/2018
Initial Date Manufacturer Received 12/07/2018
Initial Date FDA Received12/28/2018
Supplement Dates Manufacturer Received02/07/2019
Supplement Dates FDA Received02/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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