BOSTON SCIENTIFIC CORPORATION AUTOTOME RX 49; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Model Number M00545160 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/22/2022 |
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 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 49 was used in the choledochal papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, when the handle was pulled to perform sphincterotomy in the choledochal papilla, the cutting wire broke inside the papilla.It was reported that no part of the cutting wire detached and fell into the patient.The device was removed and the procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block h6 (device codes): medical device problem code a0401 captures the reportable event of cutting wire broken block h10: the returned autotome rx 49 was analyzed, and a visual evaluation noted that the cutting wire was broken from the proximal pierced hole.The device was observed under magnification and the cutting wire was broken and kinked.Additionally, the distal tip was torn from the brown mark to the tip.No other problems with the device were noted.The reported event of cutting wire break was confirmed.Upon analysis, it was found that the cutting wire was broken and kinked.Based on the condition of the device, the problem found could have been generated if there was contact between the device and the scope during energization or if the generator exceeded the maximum of voltage during the procedure.Also, energizing the device prior to performing sphincterotomy can compromise the cutting wire's integrity, which can cause a premature cutting wire fatigue and lead to a break.Once the cutting wire breaks, any attempt to remove the device from the scope can lead to the broken section of the cutting wire hitting the working channel of the scope, kinking the cutting wire.It was also found that the working length was torn.This could have been generated when the user pulled the guidewire through the c-channel or by the technique used when loading the guidewire into the device.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 an autotome rx 49 was used in the choledochal papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6).2022.During the procedure, when the handle was pulled to perform sphincterotomy in the choledochal papilla, the cutting wire broke inside the papilla.It was reported that no part of the cutting wire detached and fell into the patient.The device was removed and the procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
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