SPYGLASS RETRIEVAL BASKET

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.

Description of Event or Problem

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.

Description of Event or Problem

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.