Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.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.The spyscope was backloaded over a.035¿ guidewire; the guidewire passed freely through the working channel.A spybite device was passed freely through the working channel.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".There is an investigation in place to address this issue.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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It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the main pancreatic duct during a projection onto convex sets procedure performed on (b)(6) 2016.According to the complainant, during the procedure, when the spyscope ds was inserted in the pancreatic duct, they already noticed that the working channel of the spyscope ds was protruding.Even so, they still continued to use the device to avoid the hassle of re-insertion.As the spybite biopsy forceps was inserted, it was noticed that there was difficulty advancing the spybite through the spyscope ds which made them decide to replace the spyscope ds.Reportedly, there was no other visible damage noted and no part of the device detached.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 conclusion of the procedure was reported to be no problem.
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