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 12/06/2016 |
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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Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report# 3005099803-2016-04007 for the first spyscope digital access and delivery catheter and 3005099803-2016-04006 for the second spyscope digital access and delivery catheter.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) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, when this device was inserted into the bile duct, it was noticed on the monitor that the working channel of the spyscope ds was protruding from the distal tip.A second spyscope digital access and delivery catheter was used and same thing happened.Reportedly, no part of the device detached.The procedure was completed with a different device.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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A visual examination of the spyscope ds device found that the working channel sleeve extended from the distal cap when received.The distal tip would articulate without issue.The proximal end of the distal cap was aligned to the cap weld.A spybite device was passed freely through the working channel without issue.The distal end of the exposed working channel sleeve was tugged; it was not detached from the catheter.There was evidence that heat was applied on the outside of the catheter during manufacturing assembly.Part of the distal end of the catheter was removed to examine the working channel.Further evaluation found that there is evidence of adhesion of the working channel sleeve to the inside of the catheter.The complaint was consistent with the reported event of working channel sleeve protruding.Based on the investigation and the receipt condition/functionality, the most probable root cause is "manufacturing." an investigation addressing this issue has been completed.A dhr (device history record) review was performed and no deviation was found.A search of the complaint database confirmed that no similar complaints exist for the specified batch.
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Event Description
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Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report# 3005099803-2016-04007 for the first spyscope digital access and delivery catheter and 3005099803-2016-04006 for the second spyscope digital access and delivery catheter.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) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, when this device was inserted into the bile duct, it was noticed on the monitor that the working channel of the spyscope ds was protruding from the distal tip.A second spyscope digital access and delivery catheter was used and same thing happened.Reportedly, no part of the device detached.The procedure was completed with a different device.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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Search Alerts/Recalls
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