The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).According to the complainant, the device was disposed of and is not available for evaluation.At this time, we are unable to determine the relationship between the device and the cause for this event.If there is any further relevant information received, a supplemental medwatch report will be filed.
|
This report is one of six complaints that pertain to the same event (mfr report # 3005099803-2015-02562, 3005099803-2015-02563, 3005099803-2015-02564, 3005099803-2015-02565, 3005099803-2015-02568, and 3005099803-2015-02573).It was reported to boston scientific corporation that three (3) rx cytology brushes, an advanix biliary stent with naviflex rx delivery system, and an autotome rx sphincterotome was used during an endoscopic retrograde cholangiopancreatography (ercp) with papillotomy, brushing and biliary stent placement procedure on (b)(6) 2015.The indications for this procedure were for "chest pain, elevated lft, suspected choledocholithiasis with markedly dilated bile duct on mrcp." according to the complainant, during the procedure, an autotome rx sphincterotome was used to perform the sphincterotomy.The patient's anatomy was reported to be a dilated or larger duct after the sphincterotomy and balloon (manufacturer unknown) dilation.The olympus ercp scope was placed in a torque position.While attempting to obtain a sample from a noted distal stricture, the physician was trying to move the rx cytology brush in and out of the catheter, and the wire near the handle broke.This occurred with two (2) rx cytology brushes.The broken wire was at the user end of the catheter, outside the patient.A third rx cytology brush was used to complete that portion of the procedure, and there were no issues with this device.An advanix biliary stent was placed using a naviflex rx delivery system.Reportedly, there were no issues with the advanix biliary stent, naviflex rx delivery system, and the autotome rx sphincterotome at the conclusion of the procedure.On (b)(6) 2015, the patient's culture tested positive for e.Coli.On (b)(6) 2015, a no contrast ct was completed for the patient resulting in "no acute abnormality on no contrast ct with no evidence for pancreatitis, bowel obstruction or free air." the patient died on (b)(6) 2015 due to e.Coli sepsis.The cause of the e.Coli sepsis is unknown.
|