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
No Consequences Or Impact To Patient (2199)
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Event Date 04/02/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The patient was born in (b)(6).(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 bile duct during a cholangioscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the spyscope ds was inserted into the bile duct via a guidewire.They were able to push the device to the stenosis without resistance.When the guidewire was removed, the physician noticed that the working channel sleeve of the spyscope ds protruded.The spyscope ds was removed and replaced with a new one.The procedure was completed with the same original guidewire and the 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 conclusion of the procedure was reported to be fine.
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Manufacturer Narrative
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Block a2 (date of birth): the patient was born in 1932.Block h6 (device codes): problem code 2979 captures the reportable event of working channel sleeve protrusion.Block h10: visual assessment was performed after disinfection.As received, the black distal cap was pulled slightly off the catheter, likely a result of disinfection, handling, or shipping.Because of the condition of the device, the working channel sleeve protrusion amount could not be measured with the distal tip in neutral or when articulated.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 appear to show evidence of adhesion.These observations indicate that this device was manufactured correctly.However, the investigation of similar devices revealed a manufacturing issue related to bond b.Manufacturing process improvements have been implemented to address this issue.The complaint was consistent with the reported event of working channel sleeve protruding.Based on all gathered information, the probable cause selected for the working channel sleeve protrusion issue is manufacturing deficiency, which indicates that problems were traced to the manufacturing process.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 bile duct during a cholangioscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the spyscope ds was inserted into the bile duct via a guidewire.They were able to push the device to the stenosis without resistance.When the guidewire was removed, the physician noticed that the working channel sleeve of the spyscope ds protruded.The spyscope ds was removed and replaced with a new one.The procedure was completed with the same original guidewire and the 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 conclusion of the procedure was reported to be fine.
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