(b)(4).The analysis of the returned expect pulmonary needle noted that the needle was retracted upon receipt and the syringe and stylet were not returned.A visual evaluation found the working length (sheath and needle) were kinked at the distal end of the handle and at 3.4 cm from the distal end of the needle.A functional evaluation found the needle was difficult to extend and retract.A lab reserve syringe was attached to the handle and air was compressed into the device.Air would not pass through.A lab reserve stylet was inserted into the device and could not advance through.The handle was disassembled, and it was discovered that the needle was bent within the handle.The complaint was confirmed.The investigation concluded that this complaint is associated with a product that meets design and manufacture specifications, but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.Therefore, the most probable root cause classification for the reported failure is operational context.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.
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It was reported to boston scientific corporation that an expect pulmonary endobronchial ultrasound (ebus) transbronchial aspiration needle (tban) was used in the lungs during an ebus procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the needle was used to sample tissue from nodal station 4l.Upon attempted retrieval of the sample, the user was unable to expel the sample from the needle.The stylet was passed through the device to expel the sample, but it could not be advanced to the tip of the needle.Air, saline, and epinephrine were flushed through the needle, but the specimen could not be expelled.The procedure was completed with a different device.There were no patient complications as result of the event.The patient's condition at the conclusion of the procedure was reported to be fine.Investigation results revealed the distal end of the needle was bent; therefore, this is now an mdr reportable event.
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