BOSTON SCIENTIFIC - SPENCER SPYSCOPE DS ACCESS & DELIVERY CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
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Model Number M00546600 |
Device Problem
Material Protrusion/Extrusion (2979)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/05/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Patient's exact age is unknown; however it was reported that the patient was over the age of 18.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.
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Event Description
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It was reported to boston scientific corporation that a spyscope digital access & delivery catheter was used in the intrahepatic bile duct during a biliary direct view biopsy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the spyscope ds along with a guidewire was inserted into the patient's bile duct.At this time, it was seen on the monitor that the spyscope ds working channel protruded.Reportedly, no part of the device detached.The procedure was completed with this device.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Investigation results: a visual assessment was performed after disinfection.The working channel sleeve extended from the distal cap when received, confirming the complaint.The proximal end of the distal cap was aligned to the cap weld.There was evidence of the production bonding process and the application of heat to the outside of the catheter during manufacturing assembly, as seen in the working channel sleeve reflow/bond.A functional evaluation was performed.The distal tip articulated without issue.A spybite device was passed through the working channel without issue.The distal end of the catheter was removed to examine the working channel.The distal cap was removed from the catheter for examination.The distal end of the exposed working channel sleeve was tugged; it did not detach from the catheter.The catheter was cut open to expose the working channel sleeve.The catheter was pulled back to assess the adhesion of the working channel sleeve to the pebax; the proximal end of the working channel sleeve appeared to be attached to the pebax (bonded length).The working channel sleeve did not fall out; the working channel sleeve was pulled out of the catheter.There was evidence of adhesion of the working channel sleeve to the inside of the catheter, as seen by the white area on the proximal end of the pebax and the working channel braid imprint throughout the pebax region.The complaint was consistent with the reported event of working channel sleeve protruding.Based on the investigation and the receipt condition/functionality, the complaint conclusion investigation code selected for the working channel sleeve protrusion issue is manufacturing process design.There is an investigation in place to address this issue.A dhr (device history record) review was performed and no deviation was found.
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Event Description
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It was reported to boston scientific corporation that a spyscope digital access & delivery catheter was used in the intrahepatic bile duct during a biliary direct view biopsy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the spyscope ds along with a guidewire was inserted into the patient's bile duct.At this time, it was seen on the monitor that the spyscope ds working channel protruded.Reportedly, no part of the device detached.The procedure was completed with this device.There were no patient complications reported as a result of this event.
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