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 10/11/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(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 common bile duct (cbd during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass procedure performed on (b)(6) 2018.According to the complainant, during the procedure, while biopsy of the distal cbd was performed, the working channel sleeve protruded at the end of the spyscope ds.The spyscope ds was removed from the patient and a second spyscope digital access and delivery catheter was used.When the second spyscope ds was advanced through the channel of the endoscope, a small tubular object was seen inside the biopsy channel.It is unknown if the small tubular object was part of the first spyscope ds.The endoscope was removed from the patient and the small tubular piece was retrieved from the endoscope.Reportedly, a spybite biopsy forceps was inside the spyscope ds when the working channel sleeve protruded.No issues were reported with the spybite biopsy forceps.No issues were noted with the second spyscope ds.The procedure was completed with a third spyscope digital access and delivery catheter.There were no patient complications reported as a result of this event.The patient's condition at the end of the procedure was reported to be fine.
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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 common bile duct (cbd during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass procedure performed on (b)(6) 2018.According to the complainant, during the procedure, while biopsy of the distal cbd was performed, the working channel sleeve protruded at the end of the spyscope ds.The spyscope ds was removed from the patient and a second spyscope digital access and delivery catheter was used.When the second spyscope ds was advanced through the channel of the endoscope, a small tubular object was seen inside the biopsy channel.It is unknown if the small tubular object was part of the first spyscope ds.The endoscope was removed from the patient and the small tubular piece was retrieved from the endoscope.Reportedly, a spybite biopsy forceps was inside the spyscope ds when the working channel sleeve protruded.No issues were reported with the spybite biopsy forceps.No issues were noted with the second spyscope ds.The procedure was completed with a second spyscope digital access and delivery catheter.There were no patient complications reported as a result of this event.The patient's condition at the end of the procedure was reported to be fine.
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Manufacturer Narrative
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(b)(4).A visual assessment was performed after disinfection.As received, the working channel sleeve protruded.Maximum wcs protrusion was observed when the distal tip was articulated by turning the large knob in both directions.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 areas along bond a appear to show evidence of adhesion.A black detached object that was returned with the spyscope ds was also analyzed.It was determined to be unlikely that the black object was a spyscope ds or spybite component.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 (b)(6) 2018 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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