TRUFILL DCS ORBIT MINI COMPLEX FILL
Report
- Report Number
- 1058196-2011-00046
- Event Type
- Malfunction
- Date Received
- January 31, 2011
- Date of Event
- January 5, 2011
- Report Date
- January 6, 2011
- Manufacturer
- CORDIS NEUROVASCULAR, INC.
- Product Code
- HCG
- PMA / PMN Number
- K053197
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
A NON-STERILE TRUFILL DCS WAS RECEIVED IN TANGLED CONDITION INSIDE A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND IT WAS FOUND WITHOUT DAMAGE. THE INTRODUCER WAS RECEIVED ZIPPED WITHOUT DAMAGE. THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE FOUND INSIDE OF THE INTRODUCER. THE SUPPORT COIL AND GRIPPER WERE FOUND WITHOUT DAMAGE. THE EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER AND IT WAS FOUND STRETCHED. THE OD FROM THE DELIVERY TUBE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION ACCORDING TO DOCUMENT (B)(4). THE GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE, THE GRIPPER WAS FOUND WITHOUT DAMAGE AND THE EMBOLIC COIL WAS FOUND STRETCHED. RECEIVED TRUFILL DCS ORBIT WAS INSERTED INTO A MICROCATHETER PROWLER SELECT PLUS CORDIS LAB SAMPLE, WHICH WAS PREVIOUSLY FLUSHED, EVEN THE DAMAGES PRESENTED ON THE EMBOLIC COIL IT COULD LEAVE FROM THE MICROCATHETER'S TIP. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE FAILURES REPORTED BY THE CUSTOMER AS "COIL - IMPEDED IN MICROCATHETER AND "COIL - UNRAVELED/STRETCHED". THE COIL - IMPEDED IN MICROCATHETER WAS NOT CONFIRMED DURING THE FUNCTIONAL ANALYSIS. FOR THE COIL - UNRAVELED/STRETCHED WAS CONFIRMED. THE CAUSE OF THE COIL STRETCHED COULD NOT BE CONCLUSIVE DETERMINATE HOWEVER THESE DEFECTS COULD NOT BE RELATED TO THE MANUFACTURING PROCESS. PROCEDURAL FACTORS APPEAR TO HAVE CONTRIBUTED TO THIS FAILURE. INSPECTIONS ARE IN PLACE THAT PREVENTS THIS KIND OF FAILURES LEAVING FROM THE FACILITY. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
THE COMPLAINT RECEIVED STATES THAT DURING AN ANEURYSM COIL EMBOLIZATION PROCEDURE THE ORBIT HELICAL COIL BECAME IMPEDED IN THE MICROCATHETER AND BECAME UNRAVELED/STRETCHED. DURING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM OF THE (PCOM) POSTERIOR COMMUNICATING ARTERY, THE THIRD COIL (ORBIT HELICAL FILL 2X6) WAS ADVANCE VIA MICROCATHETER, BUT THERE WAS DIFFICULTY ADVANCING THE COIL, AND STOP ADVANCING IN THE MIDDLE SECTION OF THE PROWLER 14 MICROCATHETER. THE COIL WAS WITHDRAWN, AND THE COIL WAS STRETCHED. ANOTHER DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE THROUGH THE SAME MICROCATHETER. PRIOR TO THE EVENT TWO OTHER COILS (B)(4) WERE SUCCESSFULLY PLACED IN THE ANEURYSM. A CONSTANT AND DEDICATED SALINE WITH HEPARIN WAS UTILIZED AT ALL TIME AND DURING THE EVENT. NO ADDITIONAL TORQUE OR FORCE WAS UTILIZED DURING ADVANCING THE COIL SYSTEM THROUGH THE MICROCATHETER. THE DISTAL TIP WAS RE-SHAPED INTO A "J" WITH THE SHAPING MANDREL AND VAPOR, AND AFTER RE-SHAPING, THE MICROCATHETER WAS NOT DAMAGED. THE COIL INTRODUCER WAS SEATED CORRECTLY IN THE MICROCATHETER HUB, AND THE COIL WAS INSERTED THROUGH THE HUB, Y-CONNECTOR OR TOUHY WITHOUT ANY ISSUES. NO RESISTANCE/FRICTION OCCURRED DURING ADVANCING OR AT ANY OTHER TIME, AND THE MICROCATHETER WAS NOT AT AN ACUTE BEND. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE COIL SYSTEM OR MICROCATHETER, AND THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THE ANEURYSM SIZE WAS 4MM X 7MM. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO REPORT OF INJURY FOR THE PATIENT. A NON-STERILE TRUFILL DCS WAS RECEIVED IN TANGLED CONDITION INSIDE A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND IT WAS FOUND WITHOUT DAMAGE. THE INTRODUCER WAS RECEIVED ZIPPED WITHOUT DAMAGE. THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE FOUND INSIDE OF THE INTRODUCER. THE SUPPORT COIL AND GRIPPER WERE FOUND WITHOUT DAMAGE. THE EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER AND IT WAS FOUND STRETCHED. THE OD FROM THE DELIVERY TUBE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION ACCORDING TO DOCUMENT ES05094 REV 8 AND ES05098 REV 15. THE GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE, THE GRIPPER WAS FOUND WITHOUT DAMAGE AND THE EMBOLIC COIL WAS FOUND STRETCHED. RECEIVED TRUFILL DCS ORBIT WAS INSERTED INTO A MICROCATHETER PROWLER SELECT PLUS CORDIS LAB SAMPLE, WHICH WAS PREVIOUSLY FLUSHED, EVEN THE DAMAGES PRESENTED ON THE EMBOLIC COIL IT COULD LEAVE FROM THE MICROCATHETER'S TIP. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE FAILURES REPORTED BY THE CUSTOMER AS "COIL - IMPEDED IN MICROCATHETER" AND "COIL - UNRAVELED/STRETCHED". THE COIL - IMPEDED IN MICROCATHETER WAS NOT CONFIRMED DURING THE FUNCTIONAL ANALYSIS. FOR THE COIL - UNRAVELED/STRETCHED WAS CONFIRMED. THE CAUSE OF THE COIL STRETCHED COULD NOT BE CONCLUSIVE DETERMINATE HOWEVER THESE DEFECTS COULD NOT BE RELATED TO THE MANUFACTURING PROCESS. PROCEDURAL FACTORS APPEAR TO HAVE CONTRIBUTED TO THIS FAILURE. INSPECTIONS ARE IN PLACE AS PER 637MI021 REV. 24 THAT PREVENT THIS KIND OF FAILURES LEAVING FROM THE FACILITY. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THE COMPLAINT OF IMPEDED IN MICROCATHETER WAS NOT CONFIRMED ON ANALYSIS; HOWEVER, THE COMPLAINT OF UNRAVELED/STRETCHED WAS CONFIRMED ON ANALYSIS. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL AND PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE CONFIRMED AND NON-CONFIRMED COMPLAINTS.
DURING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM OF THE (PCOM) POSTERIOR COMMUNICATING ARTERY, THE THIRD COIL (ORBIT HELICAL FILL 2X6) WAS ADVANCE VIA MICROCATHETER, BUT THERE WAS DIFFICULTY ADVANCING THE COIL, AND STOP ADVANCING IN THE MIDDLE SECTION OF THE PROWLER 14 MICROCATHETER. THE COIL WAS WITHDRAWN, AND THE COIL WAS STRETCHED. ANOTHER DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE THROUGH THE SAME MICROCATHETER. PRIOR TO THE EVENT, TWO OTHER COILS (638MF0407 AND 637MF3575) WERE SUCCESSFULLY PLACED IN THE ANEURYSM. A CONSTANT AND DEDICATED SALINE WITH HEPARIN WAS UTILIZED AT ALL TIME AND DURING THE EVENT. NO ADDITIONAL TORQUE OR FORCE WAS UTILIZED DURING ADVANCING THE COIL SYSTEM THROUGH THE MICROCATHETER. THE DISTAL TIP WAS RE-SHAPED INTO A 'J' WITH THE SHAPING MANDREL AND VAPOR, AND AFTER RE-SHAPING, THE MICROCATHETER WAS NOT DAMAGED. THE COIL INTRODUCER WAS SEATED CORRECTLY IN THE MICROCATHETER HUB, AND THE COIL WAS INSERTED THROUGH THE HUB, Y-CONNECTOR OR TUOHY WITHOUT ANY ISSUES. NO RESISTANCE/FRICTION OCCURRED DURING ADVANCING OR AT ANY OTHER TIME, AND THE MICROCATHETER WAS NOT AT AN ACUTE BEND. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE COIL SYSTEM OR MICROCATHETER, AND THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THE ANEURYSM SIZE WAS 4MM*7MM. NO FURTHER INFORMATION WAS AVAILABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
DURING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM OF THE (PCOM) POSTERIOR COMMUNICATING ARTERY, THE THIRD COIL (ORBIT HELICAL FILL 2X6) WAS ADVANCE VIA MICROCATHETER, BUT THERE WAS DIFFICULTY ADVANCING THE COIL. THE COIL WAS WITHDRAWN, AND THE COIL WAS STRETCHED. ANOTHER DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. PRIOR TO THE EVENT TWO OTHER COILS (638MF0407 AND 637MF3575) WERE SUCCESSFULLY PLACED IN THE ANEURYSM. THE ANEURYSM SIZE WAS 4MM - 7MM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRUFILL DCS ORBIT MINI COMPLEX FILL | CNV DCS ORBIT (HCG) | HCG | CORDIS NEUROVASCULAR, INC. | NA | 15129004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | MICROCATHETER |