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

Model Number	M00546550
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a spybasket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the basket detached into the patient's common bile duct.The detached basket was retrieved using a rescue forceps and the procedure was completed with another spybasket.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block e1: (b)(6).Block h6: imdrf device code a0501 captures the reportable event of basket detached.Imdrf impact code f2301 is being used for the reportable event of rescue forceps used to retrieve the basket.

• Brand Name: SPYGLASS RETRIEVAL BASKET
• Common Device Name: 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: 17273744
• Report Number: 3005099803-2023-03468
• Device Sequence Number: 17032972
• Product Code: PTS
• UDI-Device Identifier: 08714729965886
• UDI-Public: 08714729965886
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/02/2024
• Device Model Number: M00546550
• Device Lot Number: 0028792389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown