BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
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Model Number M00546600 |
Device Problem
Material Protrusion/Extrusion (2979)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 10/11/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(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 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 tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the working channel sleeve of the spyscope ds protruded.Reportedly, no part of the spyscope ds device detached and there was no accessory device inside the spyscope ds when it protruded.The patient had minor bleeding which, according to the physician, was contributed by the working channel sleeve protrusion.There were no interventions performed to address the bleeding as the bleeding stopped on its own.The procedure was completed with a second spyscope digital access and delivery catheter.The patient's condition at the conclusion of the procedure was reported to be fine.
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Manufacturer Narrative
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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 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 working channel sleeve was removed.Witness marks were noted on the pebax.The white and clear areas along bond a, appeared 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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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 tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the working channel sleeve of the spyscope ds protruded.Reportedly, no part of the spyscope ds device detached and there was no accessory device inside the spyscope ds when it protruded.The patient had minor bleeding which, according to the physician, was contributed by the working channel sleeve protrusion.There were no interventions performed to address the bleeding as the bleeding stopped on its own.The procedure was completed with a second spyscope digital access and delivery catheter.The patient's condition at the conclusion of the procedure was reported to be fine.
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