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 Problems
Hemorrhage/Bleeding (1888); Laceration(s) (1946)
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Event Date 11/20/2018 |
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.(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 tract during a biliary tract biopsy procedure performed on (b)(6) 2018.According to the complainant, preoperative diagnosis of the patient with biliary tract cancer was performed.During the biopsy procedure, the working channel sleeve of the spyscope ds protruded.The working channel sleeve protrusion occurred after biopsies were performed 2 or 3 times near the hepatic portal.The physician performed an additional 5 biopsies and was able to complete the procedure with the original spyscope digital access and delivery catheter.Reportedly, slight bleeding was observed due to scrapping of the tumor area by the protrusion of the sleeve.The bleeding stopped on its own; therefore, no treatment was performed.There were no adverse patient effects.
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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.The problem code 2979 captures the reportable event of working channel sleeve protrusion.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 knob in the clockwise direction and the large knob in the counterclockwise direction.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 a biliary tract biopsy procedure performed on (b)(6) 2018.According to the complainant, preoperative diagnosis of the patient with biliary tract cancer was performed.During the biopsy procedure, the working channel sleeve of the spyscope ds protruded.The working channel sleeve protrusion occurred after biopsies were performed 2 or 3 times near the hepatic portal.The physician performed an additional 5 biopsies and was able to complete the procedure with the original spyscope digital access and delivery catheter.Reportedly, slight bleeding was observed due to scrapping of the tumor area by the protrusion of the sleeve.The bleeding stopped on its own; therefore, no treatment was performed.There were no adverse patient effects.
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