STONE CONE

Additional Manufacturer Narrative

BLOCKS D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H6: DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF COIL DETACHMENT. IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF UNEXPECTED MEDICAL INTERVENTION.

Description of Event or Problem

IT WAS REPORTED THAT A STONE CONE COIL RETRIEVAL WAS USED DURING THE PROCEDURE. REPORTEDLY, THE RETRIEVAL COIL DISTAL TIP FRACTURED WHILE STILL IN SITU. THE TIP WAS SUCCESSFULLY RETRIEVED, AND NO COMPONENTS WERE LEFT IN SITU. THERE WERE NO PATIENT COMPLICATIONS.

Description of Event or Problem

IT WAS REPORTED THAT A STONE CONE COIL RETRIEVAL WAS USED DURING THE PROCEDURE. REPORTEDLY, THE RETRIEVAL COIL DISTAL TIP FRACTURED WHILE STILL IN SITU. THE TIP WAS SUCCESSFULLY RETRIEVED, AND NO COMPONENTS WERE LEFT IN SITU. THERE WERE NO PATIENT COMPLICATIONS.

Additional Manufacturer Narrative

BLOCKS D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H6: DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF COIL DETACHMENT. IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF UNEXPECTED MEDICAL INTERVENTION. BLOCK H11: INVESTIGATION RESULTS: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS THEREFORE TECHNICAL ANALYSIS COULD NOT BE PERFORMED; HOWEVER, MEDIA ANALYSIS SHOWS THAT THE DISTAL END OF THE COIL IS FRACTURED. 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 CONFIRMED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. BASED ON THE INVESTIGATION RESULTS, RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. THE RESULTS OF RECORD REVIEWS DID NOT PROVIDE EVIDENCE OF A PROBABLE CAUSE. THIS INVESTIGATION WAS UNABLE TO DETERMINE A PROBABLE CAUSE FOR THE COMPLAINT EVENT. TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION AN INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED WAS ASSIGNED TO THIS INVESTIGATION.