Investigation evaluation: the device was returned with the precurved stylet in the distal tip of the device.Our laboratory evaluation of the product said to be involved confirmed the report on "cutting wire has a little deviation" based on the condition of the distal end of the returned device.A visual examination of the cutting wire showed twisting at the distal end [pointed in the wrong direction].Although the anchor remains secure in the catheter lumen, it has moved proximally by approximately 2 mm.A bend was also observed in the catheter under the cutting wire indicative of over bowing of the device.The distal end does not represent the shape at the time of manufacture.The device goes through several different inspections in manufacturing, final quality control, and packaging departments prior to leaving the facility in an effort to ensure proper orientation.Therefore, it is unknown how or at what point the cutting wire became twisted at the distal end.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: a definitive cause for this observation could not be determined because the actual product handling conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.The description of event states: "[the] customer complained the orientation of the cutting wire [was] pointing at 1 o¿clock", however, appropriate orientation is approximately 11:00 - 1:00 o'clock.Therefore, this device was within specification based on the user's comment.Improper cutting wire orientation can occur if the distal end of the catheter is shaped manually.This sphincterotome catheter is pre-curved and is provided with a pre-curved stylet in the distal tip of the catheter.This obviates the need for manual formation.The instructions for use contain the following comment: ¿note: do not apply manual pressure to tip or cutting wire of sphincterotome to influence orientation, as this may result in damage to device.¿ other factors that can contribute to improper cutting wire orientation include manipulating the handle with the catheter in a coiled position or with the precurved stylet inside the cannulating tip.The instructions for use contain the following comment: "note: do not exercise handle while device is coiled or precurved stylet is in place, as this may cause damage to sphincterotome and render it inoperable." movement of the anchor proximally can occur if the sphincterotome catheter is placed in a tightly coiled position.The instructions for use advise the user with the following statement: ¿upon removing device from package, uncoil and straighten sphincterotome.Carefully remove precurved stylet from cannulating tip.¿ the instructions for use also caution the user: "do not over flex or bow tip beyond 90 degrees." prior to distribution, all tri-tome pc protector sphincterotomes are subjected to a visual inspection and functional test to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
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