The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Note: this report pertains to a spyscope ds ii, spybite, and jagwire used during the same procedure.Refer to manufacturer report# 3005099803-2020-00067, 3005099803-2020-00069 and 3005099803-2020-00068 for the other associated device information.It was reported to boston scientific corporation that a spyscope ds ii, spybite, jagwire revolution and a non-bsc sphincterotome were used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) and cholangioscopy procedure performed on (b)(6) 2019.According to the complainant, after the procedure, the patient suffered an air embolism which was suspected to be caused by a perforation.The physician could not confirm if the perforation was related to the spyscope, spybite, guidewire, or non-bsc sphincterotome.Boston scientific has been unable to obtain additional information regarding the cause of the perforation to date, despite good faith efforts.
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