BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
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Model Number M00546600 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Inflammation (1932)
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Event Date 08/06/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6) study.(b)(4).
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Event Description
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It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019 as part of the (b)(6) study.According to the complainant, the patient had no significant medical history reported.As part of the patient's assessment, endoscopic ultrasound (eus) was performed with visibility of 3 stones, and the bile duct diameter on imaging was measured to be 5.1 mm.As the patient underwent the study procedure, he was given prophylactic antibiotics as well as indomethacin.During the procedure, a sphincterotome was also used and the imaging of the spyscope ds was rated as excellent.Four biliary stones were seen during cholangioscopy and all four biliary stones were removed.On (b)(6) 2019, the patient had post-ercp pancreatitis with moderate severity.The patient was hospitalized from (b)(6) 2019 as a result of the pancreatitis.The physician believes that there was a possible relationship between the ercp procedure and the pancreatitis.Additionally, the physician believes that there was a possible relationship between the spyscope ds and the pancreatitis.The event was considered resolved on (b)(6) 2019.
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Manufacturer Narrative
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Block g3 (study): e7131 non complex biliary stones rct study.Block h6 (patient codes): patient code 1932 captures the reportable event of pancreatitis.Block h10: conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h11: block b5 has been updated with additional information.
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Event Description
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It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019 as part of the e7131 non complex biliary stones rct study.According to the complainant, the patient had no significant medical history reported.As part of the patient's assessment, endoscopic ultrasound (eus) was performed with visibility of 3 stones, and the bile duct diameter on imaging was measured to be 5.1 mm.As the patient underwent the study procedure, he was given prophylactic antibiotics as well as indomethacin.During the procedure, a sphincterotome was also used and the imaging of the spyscope ds was rated as excellent.Four biliary stones were seen during cholangioscopy and all four biliary stones were removed.On (b)(6) 2019, the patient had post-ercp pancreatitis with moderate severity.The patient was hospitalized from (b)(6) 2019 as a result of the pancreatitis and medication (injection nacphin bd) was administered.The physician believes that there was a possible relationship between the ercp procedure and the pancreatitis.Additionally, the physician believes that there was a possible relationship between the spyscope ds and the pancreatitis.The event was considered resolved on (b)(6) 2019.
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