Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(initial reporter address): (b)(6).(b)(4).A visual examination of the device revealed that the jagwire was bent at the distal section.No failures were found on the ptfe section, therefore, the complaint was not confirmed.In addition, torque marks were observed at the middle section of the jagwire.It is likely that the failure mode observed have been caused due to interaction with the sphincterotome or when the jagwire was being inserted into the a non boston scientific duodenoscope device, if extra force was applied during usage of the jagwire, this could lead that guidewire got bent during procedure.In addition, torque marks were observed at the middle section of the jagwire, this condition could have been generated due to interaction with the torque vise during procedure.It is important to highlight that the jagwire ifu states tighten the torque vise on the guidewire until it firmly grasps the guidewire, therefore, this condition is not classified as failure mode.Based on the information available and the analysis performed, the investigation conclusion code for the complaint will be documented as adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.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).
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It was reported to boston scientific corporation that jagwire guidewire was used in the biliary system (papilla) during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2020.According to the complainant, during the procedure, when papilla was cut with a sphincterotome and guidewire was inserted in the non boston scientific duodenoscope, the ptfe peeled.This happened with seven jagwires.The procedure was cancelled based upon no additional stock available.There were no reported patient complications as a result of this event.
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