(b)(4).Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
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It was reported to boston scientific corporation that a hydratome¿ rx 44 was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the hydratome and its preloaded guidewire were removed from the patient.As they loaded bak the guidewire, it was noticed that the hydrophilic tip of the preloaded guidewire got detached, exposing the tip of the metal corewire.No parts of the device left inside the patient and there was no visible damage noted on the hydratome.The procedure was completed using a second hydratome¿ rx 44.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
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