MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS RETRIEVAL BASKET; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Model Number M00546550

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

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

Event Date 11/25/2020

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(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.

• Brand Name: SPYGLASS RETRIEVAL BASKET
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11139766
• MDR Text Key: 225779610
• Report Number: 3005099803-2020-06547
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 08714729965886
• UDI-Public: 08714729965886
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00546550
• Device Catalogue Number: 4655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 44 YR