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

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	05/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: kyushu central hospital of the mutual aid association of public school teachers.Initial reporter city fukuoka-shi, fukuoka prefecture.(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a spybasket was used in the common bile duct during an cholangioscopic lithotripsy procedure performed on (b)(6) 2022.During the procedure, the basket failed to open when attempting to grasp a stone.The procedure took a longer time than expected; therefore, the physician aborted the procedure and decided to try again next time.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) hospital.E1: initial reporter city (b)(6).Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the returned spybasket was analyzed, and a visual inspection observed the working length presented several kinks.Functional inspection found the basket could be extended and retracted without any problems.The reported event of basket failure to open was not confirmed.Based on all available information, the working length kinked may be related to user manipulation and/or some technique applied during the procedure that may have affected the working length as observed.Therefore, the most probable root cause for the problem found is adverse event related to procedure.The cause code of the reported event of basket failure to open is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a spybasket was used in the common bile duct during an cholangioscopic lithotripsy procedure performed on (b)(6) 2022.During the procedure, the basket failed to open when attempting to grasp a stone.The procedure took a longer time than expected; therefore, the physician aborted the procedure and decided to try again next time.There were no patient complications reported as a result of this event.

• 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: 14760496
• Report Number: 3005099803-2022-03341
• Device Sequence Number: 17668928
• Product Code: PTS
• UDI-Device Identifier: 08714729965886
• UDI-Public: 08714729965886
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/10/2023
• Device Model Number: M00546550
• Device Lot Number: 0026788051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2021
• 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
• Patient Sex: Unknown