STONE CONE

Additional Manufacturer Narrative

BLOCK B3: DATE OF EVENT WAS APPROXIMATED TO 10/01/2025 BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6) MEDICAL CENTER. BLOCK H6: DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF COIL DETACHMENT. BLOCK H11: INVESTIGATION RESULTS. THE RETURNED STONE CONE WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE COIL WAS TANGLED. FUNCTIONAL EXAMINATION WAS PERFORMED AND IT WAS NOTICED THAT IT WAS UNABLE TO CLOSE THE COIL ALL THE WAY. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL. THE IFU STATES THAT, IF RESISTANCE IS ENCOUNTERED WHILE ATTEMPTING TO WITHDRAW THE COIL DO NOT EXERT EXCESSIVE FORCE. TO RELEASE THE OBJECT FROM THE DEVICE, ADVANCE THE SHEATH TO STRAIGHTEN THE COIL AND REMOVE THE DEVICE. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED EVENT WAS NOT CONFIRMED. BASED ON THE ANALYSIS, THERE WAS NO DETACHMENT OR SEPARATION OBSERVED. HOWEVER, IT WAS NOTICED THAT THE COIL WAS TANGLED, AND IT WAS CLEARLY OBSERVED DEFECTS DURING PRODUCT ANALYSIS. THIS IS MOST LIKELY THAT THE DAMAGE WAS CAUSED BY USING EXCESSIVE FORCE OR MANIPULATION. ADDITIONALLY, THE TANGLED NOTED ON THE CONE PREVENTED THE CONE FROM FULLY OPENING OR CLOSING. IT IS PROBABLE THAT WHEN THEY WERE TESTING THE COIL DURING PREPARATION FORCE WAS EXERTED CAUSING THE WIRING DEFORMATION. TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION, THE MOST PROBABLE CAUSE OF THIS COMPLAINT IS UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT, INDICATING THAT INTERACTION BETWEEN THE USER AND THE DEVICE CAUSED OR CONTRIBUTED TO THE ERROR.

Description of Event or Problem

IT WAS REPORTED THAT A STONE CONE RETRIEVAL COIL WAS ABOUT TO BE USED ON A PROCEDURE. DURING UNPACKING, IT WAS OBSERVED THAT THE COIL WINDING WAS DIFFERENT FROM USUAL, AND THE WIRE OF BASKET WAS FOUND DAMAGED. ADDITIONALLY, THERE WAS A SEPARATION AND DETACHMENT OF THE BASKET PART. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

Additional Manufacturer Narrative

BLOCK B3: DATE OF EVENT WAS APPROXIMATED TO 10/01/2025 BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. BLOCK H6: DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF COIL DETACHMENT.

Description of Event or Problem

IT WAS REPORTED THAT A STONE CONE RETRIEVAL COIL WAS ABOUT TO BE USED ON A PROCEDURE. DURING UNPACKING, IT WAS OBSERVED THAT THE COIL WINDING WAS DIFFERENT FROM USUAL, AND THE WIRE OF BASKET WAS FOUND DAMAGED. ADDITIONALLY, THERE WAS A SEPARATION AND DETACHMENT OF THE BASKET PART. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.