MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	M00546600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	08/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6) study.(b)(4).
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: SPYSCOPE DS
• Common Device Name: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8934848
• Report Number: 3005099803-2019-04263
• Device Sequence Number: 439262
• Product Code: FBN
• UDI-Device Identifier: 08714729863236
• UDI-Public: 08714729863236
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K142922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/26/2020
• Device Model Number: M00546600
• Device Catalogue Number: 4660
• Device Lot Number: 0022995441
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 35 YR