ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
Report
- Report Number
- 1058196-2011-00214
- Event Type
- Malfunction
- Date Received
- May 9, 2011
- Date of Event
- January 13, 2011
- Report Date
- April 15, 2011
- Manufacturer
- CORDIS NEUROVASCULAR, INC.
- Product Code
- NJE
- PMA / PMN Number
- H60001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
THE COMPLAINT RECEIVED SATES THAT DURING AN ANEURYSM COIL EMBOLIZATION PROCEDURE THE MICRO CATHETER SELECT PLUS WAS OBSTRUCTED IN THE PATIENT AND THE ENTERPRISE STENT MICRO WIRE WAS IMPEDED. DURING A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN ADVANCED THE STENT VIA THE SELECT PLUS 150/5 CM (MC) MICROCATHETER, BUT DURING THE OPERATION, THE PHYSICIAN FOUND RESISTANCE AND IT WAS DIFFICULT TO ADVANCE THE ENTERPRISE VRD ((B)(4)) THROUGH THE DISTAL END OF THE MICROCATHETER. ADDITIONALLY, THE ENTERPRISE SYSTEM WAS DIFFICULT TO WITHDRAW, AND BOTH UNITS WERE WITHDRAWN, AND CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED WITH THE DEVICES AT ALL TIMES. NO DAMAGES WERE NOTICED IN THE DISTAL SECTION OF THE MICROCATHETER. ADDITIONALLY, THE MICROCATHETER WAS NOT RE-SHAPED. DURING THE EVENT, NO ADDITIONAL TORQUE OR FORCE WAS UTILIZED IN AN ATTEMPT TO ADVANCE THE ENTERPRISE SYSTEM THROUGH THE MICROCATHETER. AFTER REMOVAL, OTHER THAN THE REPORTED EVENT, NO DAMAGES WERE NOTICED ON THE MICROCATHETER, ENTERPRISE SYSTEM OR STENT. THERE WAS NO REPORT OF INJURY FOR THE PATIENT. ONE NON-STERILE ENTERPRISE VRD AND DELIVERY WAS RECEIVED COILED INSIDE A PLASTIC BAG; THE BAG CONTAINED THE DELIVERY WIRE-COIL TIP, INTRODUCER TUBE AND STENT, THE DELIVERY WIRE WAS INSERTED IN THE INTRODUCER TUBE AND THE STENT WAS OUTSIDE OF THE INTRODUCER TUBE AND FULLY DEPLOYED; NO VISUAL ANOMALIES WERE NOTED IN NONE OF THE COMPONENTS (DELIVERY WIRE, INTRODUCER TUBE AND STENT). STENT AND COIL TIP WERE OBSERVED UNDER THE MICROSCOPE AND NO ANOMALIES WERE FOUND. FUNCTIONAL ANALYSIS WAS PERFORMED AS PER (B)(4), AFTER EVERYTHING WAS PREPARED THE DELIVERY WIRE ADVANCED THROUGH THE INTRODUCER TUBE AND MICROCATHETER (PROWLER SELECT PLUS) AND RESISTANCE/FRICTION WAS FELT WHILE CROSSING THE KINK ON THE MICROCATHETER HOWEVER THE DELIVERY WIRE PASSED COMPLETELY THROUGH. THE SAME TEST WAS MADE WITH ANOTHER MICROCATHETER (LAB SAMPLE) AND NO RESISTANCE/FRICTION WAS FELT. NOTE: THE INVOLVED MICROCATHETER WAS RETURNED UNDER (B)(4) AND PRESENTED A KINK AND A FLATTENED SECTION. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01425458. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM (B)(4), ALONG WITH LAKE REGION MEDICAL'S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THIS PACKAGING LOT CONTAINED (B)(4) UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON (B)(4), 2010. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE FAILURE REPORTED BY THE CUSTOMER AS "DELIVERY WIRE IMPEDED-IN MICROCATHETER" WAS NOT CONFIRMED, DURING THE ANALYSIS THE DELIVERY WIRE ADVANCED COMPLETELY THROUGH THE MICROCATHETER, SOME RESISTANCE/FRICTION WAS FELT WHILE CROSSING BECAUSE OF A KINK ON THE MICROCATHETER, AND THE CAUSE OF THE EVENT EXPERIENCED BY THE CUSTOMER COULD BE RELATED TO THE DAMAGE ON THE MICROCATHETER. THE ANALYSIS AND THE DHR REVIEW INDICATES THAT THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD CONTRIBUTE TO THE EVENT AS REPORTED. THE RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THE COMPLAINT OF SELECT PLUS MICRO CATHETER OBSTRUCTED WAS CONFIRMED ON ANALYSIS AND RELATED TO SEVERAL KINKS AND FLATTENED SPOT ON THE CATHETER. THE COMPLAINT OF ENTERPRISE IMPEDED WAS NOT CONFIRMED ON ANALYSIS; ALTHOUGH, THERE WAS SOME RESISTANCE WHEN THE DEVICE REACHED THE KINKED SECTION OF THE MICROCATHETER, THE DEVICE WAS ABLE TO PASS THROUGH THE ENTIRE LENGTH SUCCESSFULLY. 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 AVAILABLE INFORMATION SUGGESTS THAT VESSEL COMPOSITION AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED AND CONFIRMED COMPLAINTS. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00214 & 1058196-2011-00215.
ONE NON-STERILE ENTERPRISE VRD AND DELIVERY WAS RECEIVED COILED INSIDE A PLASTIC BAG; THE BAG CONTAINED THE DELIVERY WIRE-COIL TIP, INTRODUCER TUBE AND STENT, THE DELIVERY WIRE WAS INSERTED IN THE INTRODUCER TUBE AND THE STENT WAS OUTSIDE OF THE INTRODUCER TUBE AND FULLY DEPLOYED; NO VISUAL ANOMALIES WERE NOTED IN NONE OF THE COMPONENTS (DELIVERY WIRE, INTRODUCER TUBE AND STENT). STENT AND COIL TIP WERE OBSERVED UNDER THE MICROSCOPE AND NO ANOMALIES WERE FOUND. FUNCTIONAL ANALYSIS WAS PERFORMED AS PER DP (B)(4), AFTER EVERYTHING WAS PREPARED THE DELIVERY WIRE-COIL TIP (WITHOUT STENT) WAS INSERTED ON THE INTRODUCER TUBE, THE DELIVERY WIRE ADVANCED THROUGH THE INTRODUCER TUBE AND MICROCATHETER (PROWLER SELECT PLUS) WITHOUT PROBLEMS, ALSO THE DELIVERY WIRE WAS REMOVED AND NO RESISTANCE/FRICTION WAS FELT. NOTE: THE INVOLVED MICROCATHETER WAS NO RETURNED, A LAB SAMPLE WAS USED FOR THIS ANALYSIS. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01425458. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM (B)(4), ALONG WITH LAKE REGION MEDICAL'S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THIS PACKAGING LOT CONTAINED (B)(4) UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON (B)(4), 2010. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE FAILURE REPORTED BY THE CUSTOMER AS "DELIVERY WIRE IMPEDED-IN MICROCATHETER" WAS NOT CONFIRMED, DURING THE ANALYSIS THE DELIVERY WIRE ADVANCED THROUGH THE MICROCATHETER WITHOUT PROBLEMS, THE CAUSE OF THE EVENT EXPERIENCED BY THE CUSTOMER COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER THE ANALYSIS AND THE DHR REVIEW INDICATES THAT THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD CONTRIBUTE TO THE EVENT AS REPORTED. THE RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00214 & 1058196-2011-00215. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
ONE NON-STERILE ENTERPRISE VRD AND DELIVERY WAS RECEIVED COILED INSIDE A PLASTIC BAG; THE BAG CONTAINED THE DELIVERY WIRE-COIL TIP, INTRODUCER TUBE AND STENT, THE DELIVERY WIRE WAS INSERTED IN THE INTRODUCER TUBE AND THE STENT WAS OUTSIDE OF THE INTRODUCER TUBE AND FULLY DEPLOYED; NO VISUAL ANOMALIES WERE NOTED IN NONE OF THE COMPONENTS (DELIVERY WIRE, INTRODUCER TUBE AND STENT). STENT AND COIL TIP WERE OBSERVED UNDER THE MICROSCOPE AND NO ANOMALIES WERE FOUND. FUNCTIONAL ANALYSIS WAS PERFORMED, AFTER EVERYTHING WAS PREPARED THE DELIVERY WIRE ADVANCED THROUGH THE INTRODUCER TUBE AND MICROCATHETER (PROWLER SELECT PLUS) AND RESISTANCE/FRICTION WAS FELT WHILE CROSSING THE KINK ON THE MICROCATHETER HOWEVER THE DELIVERY WIRE PASSED COMPLETELY THROUGH. THE SAME TEST WAS MADE WITH ANOTHER MICROCATHETER (LAB SAMPLE) AND NO RESISTANCE/FRICTION WAS FELT. NOTE: THE INVOLVED MICROCATHETER WAS RETURNED AND PRESENTED A KINK AND A FLATTENED SECTION. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01425458. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM (B)(4), ALONG WITH LAKE REGION MEDICAL'S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THIS PACKAGING LOT CONTAINED (B)(4) UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON (B)(4), 2010. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE FAILURE REPORTED BY THE CUSTOMER AS "DELIVERY WIRE IMPEDED-IN MICROCATHETER" WAS NOT CONFIRMED, DURING THE ANALYSIS THE DELIVERY WIRE ADVANCED COMPLETELY THROUGH THE MICROCATHETER, SOME RESISTANCE/FRICTION WAS FELT WHILE CROSSING BECAUSE OF A KINK ON THE MICROCATHETER, THE CAUSE OF THE EVENT EXPERIENCED BY THE CUSTOMER COULD BE RELATED TO THE DAMAGE ON THE MICROCATHETER. THE ANALYSIS AND THE DHR REVIEW INDICATES THAT THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD CONTRIBUTE TO THE EVENT AS REPORTED. THE RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00214 & 1058196-2011-00215. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORT 1058196-2011-00214 AND 1058196-2011-00215. THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
DURING A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN ADVANCED THE STENT VIA THE SELECT PLUS 150/5 CM (MC) MICROCATHETER, BUT DURING THE OPERATION, THE PHYSICIAN FOUND RESISTANCE AND IT WAS DIFFICULT TO ADVANCE THE ENTERPRISE VRD ((B)(4)) THROUGH THE DISTAL END OF THE MICROCATHETER. ADDITIONALLY, THE ENTERPRISE SYSTEM WAS DIFFICULT TO WITHDRAW, AND BOTH UNITS WERE WITHDRAWN, AND CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED WITH THE DEVICES AT ALL TIMES. NO DAMAGES WERE NOTICED IN THE DISTAL SECTION OF THE MICROCATHETER. ADDITIONALLY, THE MICROCATHETER WAS NOT RE-SHAPED. DURING THE EVENT, NO ADDITIONAL TORQUE OR FORCE WAS UTILIZED IN AN ATTEMPT TO ADVANCE THE ENTERPRISE SYSTEM THROUGH THE MICROCATHETER. AFTER REMOVAL, OTHER THAN THE REPORTED EVENT, NO DAMAGES WERE NOTICED ON THE MICROCATHETER, ENTERPRISE SYSTEM OR STENT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00214 & 1058196-2011-00215. THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
DURING A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN ADVANCED THE STENT VIA THE SELECT PLUS 150/5 CM (MC) MICROCATHETER, BUT FOUND THAT IT WAS DIFFICULT TO CROSS, AND ALSO DIFFICULTY TO WITHDRAW THE ENTERPRISE VRD (ENC452812). THEN, WITHDREW THE ENTERPRISE WITH THE MC, AND CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM | CNV ENTERPRISE SES (NJE) | NJE | CORDIS NEUROVASCULAR, INC. | NA | 01425458 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | SLECT PLUS MICROCATHETER |