ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
Report
- Report Number
- 1058196-2013-00181
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- June 16, 2013
- Report Date
- June 18, 2013
- 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
PER LAKE REGION REPORT (B)(4) LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10156885. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH LAKE REGION MEDICAL¿S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE PRODUCT WILL BE RETURNED FOR ANALYSIS, BUT IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. (B)(4).
A NON-STERILE UNIT OF ENTERPRISE VRD AND DELIVERY WAS RECEIVED INSIDE OF A PLASTIC BAG. THE ENTERPRISE WAS RECEIVED TOGETHER WITH THE MICROCATHETER INVOLVED INSIDE OF THE ORIGINAL BOXES. DELIVERY WIRE AND INTRODUCER TUBE WERE RECEIVED AND NOT DAMAGES WERE OBSERVED. THE STENT INVOLVED WAS NOT RECEIVED. ON THE MICROCATHETER WERE OBSERVED FLAT/COMPRESSED IN THE BODY. FUNCTIONAL ANALYSIS WAS INITIATED WITHOUT THE STENT. THE MICROCATHETER INVOLVED WAS USED, THE DELIVERY WIRE WAS ADVANCED THROUGH OF MICROCATHETER THIS ADVANCED WITH SLIGHT FRICTION FOR THE DAMAGES OBSERVED ON THE MICROCATHETER COMPRESSED AND HOWEVER WAS ABLE IN IT. THE DEVICE WAS INSPECTED UNDER SYSTEM VISION AND NO OTHERS DAMAGES WAS OBSERVED ONLY THE FOUND IN THE VISUAL ANALYSIS PER LAKE REGION REPORT C (B)(4) LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10156885. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH LAKE REGION MEDICAL¿S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. 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¿ CANNOT BE EVALUATED AS IS REQUIRED DUE TO THE INVOLVED STENT WAS NOT RECEIVED; THE CAUSE OF THE EVENT EXPERIENCED BY THE CUSTOMER MIGHT BE RELATED TO THE FLAT/COMPRESSED SECTION OBSERVED ON THE INVOLVED MICROCATHETER. HOWEVER THE DAMAGES FOUND ON THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED COULD NOT BE RELATED TO THE MANUFACTURING PROCESS; THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. (B)(4).
DURING THE PROCEDURE, AFTER PLACING THE PROWLER SELECT PLUS (MC) MICROCATHETER AT THE SITE, THE ENTERPRISE VRD COULD NOT BE ADVANCED AND RELEASED. THE MC AND VRD SYSTEM WERE REMOVED TOGETHER, AND THE TIP OF THE MC WAS OUT OF SHAPE (COMPRESSED). THE STENT COULD NOT CONTINUE TO USE. FINALLY THE PHYSICIAN CHANGED NEW MC AND STENT TO COMPLETE THE PROCEDURE WITHOUT ANY ADVERSE EVENT REPORTED. DURING INSERTION, THE ENTERPRISE INTRODUCER WAS COMPLETELY SEATED IN THE MICROCATHETER HUB, AND THE Y CONNECTOR OPEN SUFFICIENTLY TO ALLOW THE PASSAGE OF THE COIL DELIVERY SYSTEM/INTRODUCER. DURING INSERTION, THE TUOHY OR Y CONNECTOR WAS CLOSED TO SECURE THE COIL DELIVERY SYSTEMS/INTRODUCERS AND PREVENT MOVEMENT, AND IT IS UNKNOWN IF THE Y CONNECTOR WAS OVER TIGHTENED. NO DAMAGES WERE NOTICED ON ANY SECTION OF THE DELIVERY SYSTEM THAT MAY HAVE CONTRIBUTED TO THE EVENT, AND NO ISSUES WERE NOTED DURING REMOVAL FROM THE PLASTIC HOOP THAT MIGHT HAVE CONTRIBUTED TO THE EVENT. NO ADDITIONAL TORQUE OR MANIPULATION WAS REQUIRED TO ADVANCED OR PLACE THE MICROCATHETER, AND THE DISTAL TIP WAS NOT RESHAPED. A CONSTANT AND DEDICATED SALINE SOURCE WAS USED AT ALL TIMES THROUGH THE MICROCATHETER. AFTER THE EVENT, NO OTHER DAMAGES WERE NOTICED ON THE DEVICES (ENTERPRISE DELIVERY SYSTEM/DISTAL TIP (UNRAVELED, STRETCHED, KINK, BEND, FRACTURE, SEPARATED, ETC), OR STENT (STRUT UPLIFT OR DEFORMED, ETC). THE TARGET SITE WAS AN INTRACRANIAL ANEURYSM. THE DEVICES WILL BE RETURNED FOR ANALYSES. A NON-STERILE UNIT OF ENTERPRISE VRD AND DELIVERY WAS RECEIVED INSIDE OF A PLASTIC BAG. THE ENTERPRISE WAS RECEIVED TOGETHER WITH THE MICROCATHETER INVOLVED INSIDE OF THE ORIGINAL BOXES. DELIVERY WIRE AND INTRODUCER TUBE WERE RECEIVED AND NOT DAMAGES WERE OBSERVED. THE STENT INVOLVED WAS NOT RECEIVED. ON THE MICROCATHETER WERE OBSERVED FLAT/COMPRESSED IN THE BODY. FUNCTIONAL ANALYSIS WAS CONDUCTED WITHOUT THE STENT, AND THE MICROCATHETER INVOLVED WAS USED. THE DELIVERY WIRE WAS ADVANCED TROUGH OF MICROCATHETER, AND IT ADVANCED WITH SLIGHT FRICTION DUE TO THE DAMAGES OBSERVED ON THE MICROCATHETER COMPRESSED; HOWEVER, THE ENTERPRISE DELIVERY SYSTEM WAS ADVANCE THROUGH THE MC. THE DEVICE WAS INSPECTED UNDER SYSTEM VISION AND NO OTHERS DAMAGES WAS OBSERVED ONLY THE FOUND IN THE VISUAL ANALYSIS. LAKE REGION MEDICAL DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10156885. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH LAKE REGION MEDICAL¿S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE REPORTED FAILURE OF FAILURE TO ADVANCE ENTERPRISE SYSTEM IN THE VRD CANNOT BE EVALUATED AS IS REQUIRED DUE TO THE INVOLVED STENT WAS NOT RECEIVED; THE CAUSE OF THE EVENT EXPERIENCED BY THE CUSTOMER MIGHT BE RELATED TO THE FLAT/COMPRESSED SECTION OBSERVED ON THE INVOLVED MICROCATHETER. HOWEVER, THE DAMAGES FOUND ON THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED COULD NOT BE RELATED TO THE MANUFACTURING PROCESS; THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE FAILURES ON THE MICROCATHETER OF OBSTRUCTED AND COMPRESSED WERE CONFIRMED DURING THE FUNCTIONAL ANALYSIS. THE CAUSE OF THE FAILURE EXPERIENCED BY THE COSTUMER APPEARS WAS DUE TO THE COMPRESSED SECTIONS FOUND ON THE DEVICE BUT THIS AND THE DAMAGES FOUND ON THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED COULD NOT BE RELATED TO THE MANUFACTURING PROCESS; ADDITIONALLY INSPECTIONS ARE IN PLACE THAT PREVENTS THESE KINDS OF DAMAGES LEAVING FROM THE FACILITY. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. (B)(4).
DURING TREATMENT OF AN INTRACRANIAL ANEURYSM (4*4MM) WITH A NECK OF THE ANEURYSM WAS TOO WIDE THE STENT WAS NEEDED TO ASSIST FILLING, BUT THE ENTERPRISE VRD (ENC451412/10156885) COULD NOT BE ADVANCED AND RELEASED VIA THE PROWLER SELECT PLUS (MC) MICROCATHETER (606S255X/ 15775362). THEN, THE MC WAS REMOVED TOGETHER WITH THE VRD AND IT WAS OBSERVED THAT THE TIP OF THE MC WAS OUT OF SHAPE. THE STENT COULD NOT CONTINUE TO BE USED. FINALLY, THE MC AND STENT TO WERE CHANGED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED AND THE DEVICES WILL BE RETURNED FOR ANALYSES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311499 | ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM | CNV ENTERPRISE SES (NJE) | NJE | CORDIS NEUROVASCULAR, INC. | NA | 10156885 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | PROWLER SELECT PLUS MICROCATHETER |