(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 report will be filed.
|
It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the biliary during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass procedure performed on (b)(6) 2019.According to the complainant, during the procedure, while advancing the spybite biopsy forceps through the spyscope ds, it was noticed that the working channel sleeve of the spyscope ds protruded.There were no issues reported with the spybite biopsy forceps.The procedure was still completed using this device.There were no patient complications reported as a result of this event.
|