MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS RETRIEVAL BASKET; DISLODGER, STONE, BILIARY

Model Number	M00546550
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a051104 captures the reportable event of basket failure to release stone.Imdrf impact code f2301 captures the reportable event of rescue handle was used to break the basket.
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) 2024.During the procedure, the handle of the spybasket stopped working as the stone was being extracted.The basket would not open or close anymore, and the stone got trapped in the distal common bile duct.A rescue handle was used to break the basket.A different model was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a051104 captures the reportable event of basket failure to release stone.Imdrf impact code f2301 captures the reportable event of rescue handle was used to break the basket.Block h2: block b5 has been updated based on additional information received on august 15, 2024.
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) 2024.During the procedure, the handle of the spybasket stopped working as the stone was being extracted.The basket would not open or close anymore, and the stone got trapped in the distal common bile duct.A rescue handle was used to break the basket.A different model was used to complete the procedure.There were no patient complications as a result of this event.***additional information received on august 15, 2024.*** the rescue handle used was a soehendra handle.
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) 2024.During the procedure, the handle of the spybasket stopped working as the stone was being extracted.The basket would not open or close anymore, and the stone got trapped in the distal common bile duct.A rescue handle was used to break the basket.A different model was used to complete the procedure.There were no patient complications as a result of this event.Additional information received on august 15, 2024.The rescue handle used was a soehendra handle.Additional information received on september 24, 2024.The stone was about 8mm.
Additional Manufacturer Narrative
Block h6: imdrf device code a051104 captures the reportable event of basket failure to release stone.Imdrf impact code f2301 captures the reportable event of rescue handle was used to break the basket.Block h2: block b5 has been updated based on additional information received on august 15, 2024.Block h2: block b5 has been updated based on additional information received on september 24, 2024.

• Brand Name: SPYGLASS RETRIEVAL BASKET
• Common Device Name: DISLODGER, STONE, BILIARY
• 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: 19967853
• Report Number: 3005099803-2024-03773
• Device Sequence Number: 8784550
• Product Code: LQR
• UDI-Device Identifier: 08714729965886
• UDI-Public: 08714729965886
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K071066
• 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,Followup,Followup
• Report Date (Section B): 10/16/2024

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: 09/26/2025
• Device Model Number: M00546550
• Device Lot Number: 0032513755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 08/15/2024; 09/24/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/05/2024; 10/16/2024
• Date Device Manufactured: 09/27/2023
• 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