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

Model Number	M00546550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2023
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 a laparoscopic cholecystectomy with common bile duct exploration procedure performed on (b)(6) 2023.During a procedure, a spyglass retrieval basket was used to capture a large stone in the common bile duct.However, when the basket was closed, the wire of the basket broke leaving the stone trapped inside.Further incision on the patient's common bile duct was performed in order to extract the broken basket and stone.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
D3: the complainant was unable to provide the suspect device upn and lot number; therefore, the expiration and device manufacture dates are unknown.Block h6: imdrf device code a0401 captures the reportable event of basket wire break.Impact code f23 captures the reportable event of further incision on the patient's common bile duct was performed in order to extract the broken basket and stone.

• 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: 17197381
• Report Number: 3005099803-2023-03293
• Device Sequence Number: 6592278
• Product Code: PTS
• UDI-Device Identifier: 08714729965886
• UDI-Public: 08714729965886
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 06/26/2023

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 Model Number: M00546550
• Device Catalogue Number: 4655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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