GALAXY G3 MINI 2.00MM X 4.00CM
Report
- Report Number
- 3008114965-2018-00531
- Event Type
- Malfunction
- Date Received
- February 12, 2018
- Date of Event
- January 19, 2018
- Report Date
- January 19, 2018
- Manufacturer
- REFER TO SECTION H10
- Product Code
- KRD
- UDI-DI
- 10886704080305
- PMA / PMN Number
- K171862
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
PRODUCT COMPLAINT # (B)(4). DESCRIBE EVENT OR PROBLEM: ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE COIL SEPARATED DURING THE PROCEDURE. TRACKING/PUSHING THE COIL THROUGH THE MICROCATHETER WAS DIFFICULT. PROCODE: KRD/HCG. COMPLAINT CONCLUSION: AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A MODERATELY TORTUOUS 4MM X 6MM X 5MM MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION ANEURYSM, RESISTANCE WAS ENCOUNTERED ADVANCING THE 2MM X 4CM GALAXY G3 MINI 9 STRETCH RESISTANT THERMO-MECHANICAL DETACHABLE COIL DELIVERY SYSTEM (DCS) (GLM920040/S15113) THROUGH THE TOTAL LENGTH OF THE PHENOM .017 (MEDTRONIC) MICROCATHETER. THE PHYSICIAN HAD DIFFICULTY PLACING THE COIL INTO THE ANEURYSM. IT APPEARED THE COIL HAD ALREADY STRETCHED. THE PHYSICIAN SUSPECTED THAT THE COIL STRETCHED HALFWAY INTO THE ANEURYSM. THE COIL WAS REMOVED WITH THE MICROCATHETER FROM THE PATIENT AND THE PROCEDURE WAS CONCLUDED. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT AS A RESULT OF THE EVENT. THE EVENT DID NOT RESULT IN A PROCEDURAL DELAY. THE COMPLAINT PRODUCT WAS THE TENTH AND LAST COIL TO BE USED IN THE CASE. NINE OTHER COILS WENT THROUGH THE SAME MICROCATHETER WITHOUT RESISTANCE. THERE WAS NO RESISTANCE FELT BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN ACCESSING THE TARGET SITE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WERE NO KINKS IN THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE COIL WAS NOT USED LIKE A GUIDEWIRE TO REPOSITION THE MICROCATHETER. THE COIL NEITHER SEPARATED NOR DETACHED FROM THE DEVICE POSITIONING UNIT (DPU). ADDITIONAL INFORMATION RECEIVED AFTER THE FAILURE ANALYSIS WAS COMPLETE INDICATED THAT THE EMBOLIC COIL SEPARATED DURING THE PROCEDURE AS TRACKING/PUSHING THE COIL THROUGH THE MICROCATHETER WAS DIFFICULT. THERE WAS NO EVIDENCE OF COIL PROTRUSION FROM THE PARENT VESSEL. IT IS NOT KNOWN IF THERE WAS POOR CONFORMABILITY AND IF COIL ENTANGLEMENT WITH PREVIOUSLY PLACED COILS CONTRIBUTED TO THE EVENT. NO FURTHER INFORMATION WAS PROVIDED. A NON-CERENOVUS MICROCATHETER WAS RETURNED. PART OF A STRETCHED EMBOLIC COIL WAS VISIBLE EMERGING FROM THE PROXIMAL END OF THE MICROCATHETER. NO DEVICE POSITIONING UNIT (DPU) WAS RETURNED. THE EMBOLIC COIL WAS SEPARATED, AND THE PROXIMAL SECTION WAS NOT RETURNED. THE BREAK APPEARED TO BE DUCTILE. AN ATTEMPT WAS MADE TO REMOVE THE EMBOLIC COIL FROM THE MICROCATHETER. THE EMBOLIC COIL WAS FIRMLY LODGED IN THE MICROCATHETER AND COULD NOT BE REMOVED. BECAUSE THE MAJORITY OF THE DEVICE WAS NOT RETURNED, AND BECAUSE THE PART OF THE DEVICE THAT WAS RETURNED IS LODGED IN THE MICROCATHETER, ADVANCEMENT OF THE EMBOLIC COIL COULD NOT BE TESTED. THE EMBOLIC COIL WAS NOT VISIBLE AT THE DISTAL END OF THE MICROCATHETER. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THE COMPLAINT OF POSITIONING DIFFICULTY COULD NOT BE DIRECTLY TESTED IN THE LAB. THE COMPLAINT OF RESISTANCE OR FRICTION DURING ADVANCEMENT WAS CONFIRMED. WHILE ADVANCEMENT COULD NOT BE TESTED BECAUSE THE COMPLETE DEVICE WAS NOT RETURNED, THE EMBOLIC COIL WAS LODGED IN THE MICROCATHETER AND COULD NOT BE MOVED. THE COMPLAINT THAT THE EMBOLIC COIL UNRAVELED OR STRETCHED WAS CONFIRMED. THE EMBOLIC COIL WAS SEVERELY STRETCHED. THE EMBOLIC COIL WAS ALSO SEPARATED, AND THE PROXIMAL END AND DPU WERE NOT RETURNED. THE HYPOTHESIS THAT THE COIL STRETCHED WHILE BEING POSITIONED IN THE ANEURYSM CANNOT BE CONFIRMED, AS THERE IS NO PART OF THE EMBOLIC COIL VISIBLE AT THE DISTAL END OF THE MICROCATHETER. STRETCHING OF THE EMBOLIC COIL OCCURS WHEN AN ATTEMPT IS MADE TO RETRACT THE DEVICE WHILE A MORE DISTAL PART OF THE EMBOLIC COIL IS HELD IN POSITION, POSSIBLY BY THE RESISTANCE NOTED IN THE EVENT DESCRIPTION. WHILE THE EXACT CIRCUMSTANCES ARE UNKNOWN, THE EVENT DESCRIPTION INDICATES THAT THE EMBOLIC COIL SEPARATED DURING THE PROCEDURE. THE NATURE OF THE BREAK SUGGESTS THAT IT OCCURRED AS PART OF THE SAME EVENT THAT CAUSED THE EMBOLIC COIL TO STRETCH. WITHOUT RETURN OF THE DPU AND INTRODUCER, THE CAUSE OF THE RESISTANCE CANNOT BE IDENTIFIED. IT IS POSSIBLE THAT CLINICAL/PROCEDURAL FACTORS AND THE CONCOMITANT MICROCATHETER MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; HOWEVER, BASED ON THE ANALYSIS, A DEFINITIVE ROOT CAUSE CONCLUSION REGARDING THE REPORTED EVENTS CANNOT BE DETERMINED. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
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
PRODUCT COMPLAINT # (B)(4). PHYSICAL MANUFACTURER: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)) PHYSICAL MANUFACTURER: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)) THE PRODUCT AND ASSOCIATED MICROCATHETER WERE RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A MODERATELY TORTUOUS 4MM X 6MM X 5MM MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION ANEURYSM, RESISTANCE WAS ENCOUNTERED ADVANCING THE 2MM X 4CM GALAXY G3 MINI 9 STRETCH RESISTANT THERMO-MECHANICAL DETACHABLE COIL DELIVERY SYSTEM (DCS) (GLM920040/S15113) THROUGH THE TOTAL LENGTH OF THE PHENOM .017 (MEDTRONIC) MICROCATHETER. THE PHYSICIAN HAD DIFFICULTY PLACING THE COIL INTO THE ANEURYSM. IT APPEARED THE COIL HAD ALREADY STRETCHED. THE PHYSICIAN SUSPECTED THAT THE COIL STRETCHED HALFWAY INTO THE ANEURYSM. THE COIL WAS REMOVED WITH THE MICROCATHETER FROM THE PATIENT AND THE PROCEDURE WAS CONCLUDED. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT AS A RESULT OF THIS EVENT. THE EVENT DID NOT RESULT IN A PROCEDURAL DELAY. THE COMPLAINT PRODUCT WAS THE TENTH AND LAST COIL TO BE USED IN THE CASE. NINE OTHER COILS WENT THROUGH THE SAME MICROCATHETER WITHOUT RESISTANCE THERE WAS NO RESISTANCE FELT BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN ACCESSING THE TARGET SITE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WERE NO KINKS IN THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE COIL WAS NOT USED LIKE A GUIDEWIRE TO REPOSITION THE MICROCATHETER. THE COIL NEITHER SEPARATED NOR DETACHED FROM THE DEVICE POSITIONING UNIT (DPU). THERE WAS NO EVIDENCE OF COIL PROTRUSION FROM THE PARENT VESSEL. IT IS UNKNOWN IF THERE WAS POOR CONFORMABILITY AND IF COIL ENTANGLEMENT WITH PREVIOUSLY PLACED COILS CONTRIBUTED TO THE EVENT. THE COMPLAINT PRODUCT AND ASSOCIATED MICROCATHETER WILL BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 108762 | GALAXY G3 MINI 2.00MM X 4.00CM | DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION | KRD | REFER TO SECTION H10 | S15113 | 10886704080305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | PHENOM .017 (MEDTRONIC) MICROCATHETER |