BOSTON SCIENTIFIC CORPORATION RX NEEDLE KNIFE XL; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Model Number M00545840 |
Device Problems
Material Deformation (2976); Appropriate Term/Code Not Available (3191)
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Patient Problems
Swelling (2091); Swelling/ Edema (4577)
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Event Date 11/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(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 medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that a rx needle knife xl was used in the biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, when the needle knife was advanced into the duodenoscope and the needle was extended, it was noticed that the needle was bent.The device was removed from the duodenoscope and attempts to straighten the needle were not successful.Reportedly, there was no damage to the device out of the package.Additionally, there was swelling noted in the anatomy after the device was removed as a result of "trying to get in up until that point".The procedure was rescheduled to allow the swelling to subside.The procedure was successfully completed a couple days later using a jagtome revolution device.
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Manufacturer Narrative
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Block h6 (device codes): medical device problem code a27 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: the returned rx needle knife xl was analyzed, and a visual evaluation noted that the cutting wire was bent.A dimensional and functional evaluation noted that the cutting wire extension length and handle actuation were within specifications.No other issues with the device were noted.The reported swelling is a known inherent risk of the device and is listed as a potential risk of the device in the device's instructions for use.The reported event was confirmed.Upon analysis, it was found that cutting wire was bent.Based on the condition of the device, the problem found could be caused by manipulation of the device during the procedure, or if the cutting wire was not fully retracted when advancing into the endoscope.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
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Event Description
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It was reported to boston scientific corporation that a rx needle knife xl was used in the biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, when the needle knife was advanced into the duodenoscope and the needle was extended, it was noticed that the needle was bent.The device was removed from the duodenoscope and attempts to straighten the needle were not successful.Reportedly, there was no damage to the device out of the package.Additionally, there was swelling noted in the anatomy after the device was removed as a result of "trying to get in up until that point".The procedure was rescheduled to allow the swelling to subside.The procedure was successfully completed a couple days later using a jagtome revolution device.
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