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 distal tip was bent.No failures were found on the ptfe section, therefore the complaint was not confirmed.It is likely the failure mode observed has been caused due to interaction with the sphincterotomy or when the jagwire was being inserted into a non boston scientific duodenoscope device, if extra force was applied during usage of the jagwire, this could have lead to the distal tip becoming bent during the procedure.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).
|
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.
|