The exact patient age is unknown; however, she was reported to be in her 70's.The exact date of death was not provided, but it was reported to be before sunday (b)(6) 2018.The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.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 truetome 39 sphincterotome was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure for stone removal performed on (b)(6) 2018.According to the complainant, after gaining access to the duct with a guidewire, the truetome device was used for endoscopic sphincterotomy (est) at the ampulla.Incidentally, the physician commented that he did not like that the device used a "short-wire" guidewire system; he prefers long-wire.The patient had a diverticulum near the ampulla.Despite this, the physician performed the sphincterotomy procedure.During sphincterotomy, the physician cut into an artery near the diverticulum which resulted in hemorrhage.The physician performed suction, applied epinephrine, and repeatedly flushed the site to staunch the bleed, but no clipping or other escalated measures were performed to achieve hemostasis.Reportedly, the bleed slowed enough to continue with the procedure.After sphincterotomy, a balloon sweep was performed for stone removal and a plastic stent was placed for biliary drainage.Reportedly, the physician believed he had done enough to achieve hemostasis during the procedure, and at the end of the procedure the physician indicated he believed there to be no complications.However, at some point post-procedure (time unknown), the patient experienced blood loss per rectum.On (b)(6) 2018 (the day following the procedure) an esophagogastroduodenoscopy (egd) procedure was performed by the physician to assess the bleed.The results of this assessment, and any actions taken, are unknown.The patient later passed away.The exact date of the patient's death was not reported; however, it was reported that the patient passed away some time before (b)(6) 2018.
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