BOSTON SCIENTIFIC CORPORATION AUTOTOME RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Model Number M00545170 |
Device Problems
Failure to Fold (1255); Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/19/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This event was reported by the distributor.The physician is: (b)(4).(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem 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 an autotome rx 44 was used in the papilla during an endoscopic sphincterotomy(est) procedure performed on (b)(6) 2021.During the procedure, initially when this device exited the scope, the orientation of the catheter tip and the cutting wire were both correct and they were able to cannulate into the bile duct.However, when they performed est, it was noticed that the direction of the cutting wire was in an abnormal orientation.They tried to grasp the handle to bow the device but they could not stretch it.Est was performed in the same manner and the procedure was completed.There were no patient complications reported as a result of this event.
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Event Description
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It was reported to boston scientific corporation that an autotome rx 44 was used in the papilla during an endoscopic sphincterotomy(est) procedure performed on (b)(6)2021.During the procedure, initially when this device exited the scope, the orientation of the catheter tip and the cutting wire were both correct and they were able to cannulate into the bile duct.However, when they performed est, it was noticed that the direction of the cutting wire was in an abnormal orientation.They tried to grasp the handle to bow the device but they could not stretch it.It was reported that there was no visible damage to the device prior to putting it through the scope and after the issue occurred.Est was performed in the same manner and the procedure was completed.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Section e: this event was reported by the distributor.The physician is: (b)(6) block h6 (device codes): medical device problem code a1502 captures the reportable event of incorrect cutting wire orientation.Block h10: the returned autotome rx 44 was analyzed, and a visual evaluation noted that the cutting wire was blackened and the working length was torn at the distal section.The torn area had evidence of melting.A functional evaluation was performed by introducing the device into the scope using short and deliberate movements and it was noted that the initial orientation of the device was correct when the distal tip was extended approximately 25mm past the elevator of the duodenoscope.Additionally, bowing test was perform outside and inside the scope, the device bowed and returned from bowed position as intended.No other problems with the device were noted.The reported event was not confirmed.The orientation of the device was correct when it exited the scope.Upon analysis, it was found that the cutting wire was blackened and the distal section of the working length was slightly torn.Cutting wire blackened indicates that the device was energized during its use and contact with the tissue could have caused the blackened appearance.Also, tearing in the working length with evidence of melting suggest that the component was submitted to heat and it could have torn the distal section of the working length, which could have affected the overall performance of the device at the moment to bow the device.It is most likely that procedural or anatomical factors encountered during procedure could have affected the device performance and its integrity.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.Block h11 (correction): block b5 and e1 (initial reporter zip/post code) has been corrected.
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