BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
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Model Number M00546600 |
Device Problems
Detachment of Device or Device Component (2907); Material Protrusion/Extrusion (2979)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.(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.
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Event Description
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It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure.According to the complainant, during procedure, it was noticed that the working channel sleeve of the spyscope ds protruded.There was no accessory device inside the spyscope ds when the working channel sleeve protruded.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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Manufacturer Narrative
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Date of event: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Device codes: problem code 2979 captures the reportable event of working channel sleeve protrusion.A visual assessment was performed.The catheter demonstrated signs of use.The outer ring of the distal cap was separated from the catheter.Although the camera wires, plastic optical fibers (pofs), and working channel sleeve (wcs) were exposed, they appear intact.There is evidence that heat was applied to the outside of the catheter during manufacturing assembly.There is evidence of laser weld marks on the cap and the ring.The distal tip was cut.The distal cap was removed.The catheter was cut open using the cutting fixture.The wcs was removed.Witness marks were noted on the pebax.The white and clear areas along bond a appear to show evidence of adhesion.Although the amount of wcs protrusion, if any, was unable to be confirmed due to the separated distal cap, the condition of bond b is consistent with returned complaint devices that do have wcs protrusion.Therefore, the complaint is confirmed.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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Event Description
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It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure.According to the complainant, during procedure, it was noticed that the working channel sleeve of the spyscope ds protruded.There was no accessory device inside the spyscope ds when the working channel sleeve protruded.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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