ENSNARE ENDOVASCULAR SNARE SYSTEM
Received Aug 14, 2024 · Event occurred Jul 9, 2024
Report 9616662-2024-00026 · MDR key 19983220
Device
Generic name
Endovascular Snare System
Manufacturer
Merit Medical Systems, Inc.Catalog number
EN2007030/C
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
PER MW5157536: THE ACCOUNT ALLEGES THAT A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE AN RA AND RV LEAD DUE TO NON-FUNCTION. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO THE LEADS TO PROVIDE TRACTION. DURING THE PROCEDURE, THE LEAD'S INNER LUMENS BROKE AND THE LLDS WERE REMOVED IN THEIR ENTIRETY, LEAVING BEHIND THE LEAD'S OUTER INSULATION AND CABLING. TO ATTEMPT TO REMOVE THE LEAD REMNANTS, SNARING WAS PERFORMED, USING A COOK MEDICAL NEEDLE'S EYE SNARE, ALONG WITH A MERIT MEDICAL ENSNARE ENDOVASCULAR SNARE SYSTEM, AND A MEDTRONIC AMPLATZ GOOSENECK SNARE. THE RA LEAD REMNANT WAS SUCCESSFULLY REMOVED. WHILE ATTEMPTING TO REMOVE THE RV LEAD REMNANT, THE LEAD DISINTEGRATED WITH USE OF THE SNARE, BREAKING THE RV LEAD REMNANT INTO MULTIPLE PIECES. A LONG 7-8 CM SECTION OF LEAD REMAINED IN THE RV, UNABLE TO EXTRACT. ADDITIONALLY, FRAGMENTS OF THE RV LEAD WERE LEFT IN THE RA. A SMALL 1 CM SECTION OF OUTER INSULATION MIGRATED (EMBOLIZED) INTO THE PATIENT'S RIGHT LUNG. THE PROCEDURE WAS STOPPED AFTER APPROXIMATELY 8 HOURS OF ATTEMPTED EXTRACTION AND 2 HOURS OF FLUOROSCOPY. THE PATIENT WAS STABLE AT THE END OF THE PROCEDURE AND A MULTIDISCIPLINARY TEAM MEETING WITH SURGICAL COLLEAGUES WAS PLANNED TO DISCUSS FURTHER TREATMENT.
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED.