MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS II ACCESS & DELIVERY CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M00546610

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); No Code Available (3191); Pancreatitis (4481)

Event Date 11/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).E7131 non complex biliary stones randomized control trial (rct) study.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

Note: this report pertains to a spyscope ds ii access and delivery catheter and a spyglass retrieval basket that were used in the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access and delivery catheter and a spyglass retrieval basket were used in the biliary system during a cholangioscopy with biliary sphincterotomy procedure performed on (b)(6) 2020 as part of the e7131 non complex biliary stones randomized control trial (rct) study.According to the complainant, the patient was already taking antibiotics and was given indomethacin prior to the procedure.Cannulation in the pancreatic duct was performed using a sphincterotome and wire.Cannulation was completed one time with the eventual standard biliary cannulation having success within 15 minutes of initiating the procedure.A spyscope ds ii access and delivery catheter was used and the image was reportedly good.During cholangioscopy, two biliary stones were seen along with sludge.Biliary sphincterotomy was then performed.A spyglass retrieval basket was used to remove the stones along with the sludge or debris.On (b)(6) 2020, the patient presented with acute pancreatitis.Reportedly, the patient was hospitalized for a prolonged period of time as a result of the pancreatitis.The patient was reported to be recovering.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

Note: this report pertains to a spyscope ds ii access and deliverycatheter and a spyglass retrieval basket that were used in the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access and delivery catheter and a spyglass retrieval basket were used in the biliary system during a cholangioscopy with biliary sphincterotomy procedure performed on (b)(6) 2020 as part of the e7131 non complex biliary stones randomized control trial (rct) study.According to the complainant, the patient was already taking antibiotics and was given indomethacin prior to the procedure.Cannulation in the pancreatic duct was performed using a sphincterotome and wire.Cannulation was completed one time with the eventual standard biliary cannulation having success within 15 minutes of initiating the procedure.A spyscope ds ii access and delivery catheter was used and the image was reportedly good.During cholangioscopy, two biliary stones were seen along with sludge.Biliary sphincterotomy was then performed.A spyglass retrieval basket was used to remove the stones along with the sludge or debris.On (b)(6) 2020, the patient presented with acute pancreatitis.Reportedly, the patient was hospitalized for a prolonged period of time as a result of the pancreatitis.The patient was reported to be recovering.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.The following additional information was received from the clinical site on august 20, 2021: on (b)(6) 2020, the reported event acute pancreatitis was resolved.The patient's adverse event of acute pancreatitis has been confirmed to be unlikely to be causally related to the boston scientific device.It was stated that there was an inadvertent pancreatic duct (pd) cannulation using a sphincterotome and wire, and had a probable relationship of acute pancreatitis to ercp procedure.Furthermore, it was also stated that the device relationship is unlikely related to the spyscope ds ii access and delivery catheter.

Manufacturer Narrative

Block e1 (initial reporter facility name): (b)(6) hospital.Block g3: e7131 non complex biliary stones randomized control trial (rct) study.Block h6 (patient codes): patient code e1021 is being used to capture the reportable event of pancreatitis requiring hospitalization.Block h6 (impact codes): impact code f08 captures the reportable event of hospitalization.Block h6: conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.Block h2 additional information: block b5 has been updated based on additional information received august 20, 2021.

• Brand Name: SPYSCOPE DS II ACCESS & DELIVERY CATHETER
• Type of Device: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11139486
• MDR Text Key: 225778617
• Report Number: 3005099803-2020-06548
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• PMA/PMN Number: K181439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2022
• Device Model Number: M00546610
• Device Catalogue Number: 4661
• Device Lot Number: 0026073317
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 08/20/2021
• Supplement Dates FDA Received: 09/10/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 44 YR