TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX
Report
- Report Number
- 1058196-2011-00110
- Event Type
- Malfunction
- Date Received
- March 18, 2011
- Date of Event
- February 7, 2011
- Report Date
- February 20, 2011
- Manufacturer
- CORDIS NEUROVASCULAR, INC.
- Product Code
- HCG
- PMA / PMN Number
- K053197
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. EMBOLIC COIL WAS RECEIVED IN A SEPARATED SMALL BAG; IT WAS STRETCHED AT PROXIMAL SIDE AND DISTAL SECTION PRESENTED KINKS. RESIDUES OF BLOOD WERE OBSERVED IN THE EMBOLIC COIL. INTRODUCER WAS UNZIPPED AND PRESENTED SOME WAVES. HYPOTUBE WAS INSPECTED AND KINKS WERE NOTED ON IT. NEITHER THE SUPPORT COIL NOR THE GRIPPER PRESENTED DAMAGES. EMBOLIC COIL WAS BROKEN SINCE THE HEADPIECE REMAIN ATTACHED TO THE GRIPPER AND THE REST OF THE COIL WAS RECEIVED IN A SMALL BAG. THE PRODUCT WAS INSPECTED UNDER MICROSCOPE AND THE GRIPPER WAS FOUND WITHOUT DAMAGE; AS WELL THE BROKEN COIL COULD BE OBSERVED DUE TO ONLY THE HEADPIECE WAS ATTACHED TO THE GRIPPER. MICROSCOPIC ANALYSIS SHOWED A WEDGE OF SOLDER STILL ATTACHED TO THE COIL HEADPIECE, IN THE AREA BETWEEN THE COIL LOOPS. THIS INDICATES THAT THE SOLDER HAD GOOD ADHESION TO THE COIL HEADPIECE. 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. REVIEW OF LOT 15195849 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. REPORTED FAILURE BY THE CUSTOMER AS "COIL PREMATURE DETACHED" WAS NOT CONFIRMED DUE TO THE HEADPIECE WAS STILL ATTACHED TO THE GRIPPER; HOWEVER THE EMBOLIC COIL WAS BROKEN. THE CAUSE OF THE BROKEN IN THE EMBOLIC COIL COULD BE A EXCESS OF FORCE APPLIED SINCE ACCORDING THE CONDITION OF THE RECEIVED PRODUCT THE EMBOLIC COIL GOT STRETCHED BEFORE IT BROKEN. THE CAUSE OF THE KINKS AND STRETCHED CONDITIONS ON THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER PER PQS INVESTIGATION THE CUSTOMER INDICATE THAT THERE WERE NO DAMAGES NOTICE IN THE DEVICE; THEREFORE THERE ARE NO INDICATIONS THAT THE REPORTED FAILURE IS RELATED TO THE MANUFACTURING PROCESS. NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THE DAMAGE COULD HAVE BEEN RELATED TO THE MANUFACTURING PROCESS. PROCEDURAL FACTORS APPEAR TO HAVE IMPACTED ON THE FAILURE REPORTED; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
IT WAS REPORTED THAT THE ORBIT RDFL COMPLEX FILL COIL PREMATURELY DETACHED. ADDITIONALLY IT WAS REPORTED THAT THE COIL ALSO STRETCHED. THE EVENT OCCURRED DURING PLACEMENT OF THE COIL IN AN UNKNOWN INTRACEREBRAL ANEURYSM AND DETACHED IN THE UNKNOWN CODMAN MICROCATHETER. THERE WAS NO RESISTANCE AT ANYTIME WITH THE MICROCATHETER. DUE TO THE PHYSICIAN'S EXPERIENCE WITH THE PRODUCT, IT WAS ABLE TO BE RETRIEVED WITH NO HARM TO THE PATIENT. IT IS NOT KNOWN HOW THE COIL WAS REMOVED. THE MICROCATHETER HAD NOT BEEN RE-SHAPED AND A CONSTANT AND DEDICATED FLUSH MAINTAINED AT ALL TIMES. THERE WAS NO ADDITIONAL TORQUE OR MANIPULATION OF THE DEVICE DURING DELIVERY AND NO RESISTANCE/FRICTION. A ONE-TO-ONE WAS VERIFIED BETWEEN THE COIL AND DELIVERY SYSTEM. IT IS NOT KNOWN IF THE MICROCATHETER HAD BEEN REPOSITIONED OVER THE DEPLOYED COIL, WHICH THE INSTRUCTIONS FOR USE PRECAUTIONS MAY LEAD TO COIL DAMAGE OR DETACHMENT. A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. EMBOLIC COIL WAS RECEIVED IN A SEPARATED SMALL BAG; IT WAS STRETCHED AT PROXIMAL SIDE AND DISTAL SECTION PRESENTED KINKS. RESIDUES OF BLOOD WERE OBSERVED IN THE EMBOLIC COIL. INTRODUCER WAS UNZIPPED AND PRESENTED SOME WAVES. HYPOTUBE WAS INSPECTED AND KINKS WERE NOTED ON IT. NEITHER THE SUPPORT COIL NOR THE GRIPPER PRESENTED DAMAGES. EMBOLIC COIL WAS BROKEN SINCE THE HEADPIECE REMAIN ATTACHED TO THE GRIPPER AND THE REST OF THE COIL WAS RECEIVED IN A SMALL BAG. THE PRODUCT WAS INSPECTED UNDER MICROSCOPE AND THE GRIPPER WAS FOUND WITHOUT DAMAGE; AS WELL THE BROKEN COIL COULD BE OBSERVED DUE TO ONLY THE HEADPIECE WAS ATTACHED TO THE GRIPPER. MICROSCOPIC ANALYSIS SHOWED A WEDGE OF SOLDER STILL ATTACHED TO THE COIL HEADPIECE, IN THE AREA BETWEEN THE COIL LOOPS. THIS INDICATES THAT THE SOLDER HAD GOOD ADHESION TO THE COIL HEADPIECE. 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. BASED ON THE ANALYSIS OF THE RETURNED DEVICE, THE FAILURE MODE WAS COIL SEPARATION FROM THE HEAD-PIECE NOT PREMATURE DEPLOYMENT OF THE COIL FROM THE DELIVERY SYSTEM. THE CAUSE OF THE BROKEN EMBOLIC COIL MAY BE DUE TO AN EXCESS OF FORCE APPLIED SINCE ACCORDING THE CONDITION OF THE RECEIVED PRODUCT AND PER THE REPORTED INFORMATION, IT APPEARS THAT THE EMBOLIC COIL GOT STRETCHED BEFORE IT BROKE. THE CAUSE OF THE KINKS AND STRETCHED CONDITIONS ON THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED. IT APPEARS THAT PROCEDURAL FACTORS MAY HAVE IMPACTED THE EVENT. WITH REVIEW OF THE RETURNED DEVICE AND THE DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.
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. REVIEW OF LOT 15195849 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). THE NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. COIL ASSEMBLY LOT # 15191189 WAS REVIEWED AND REVEALED ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT,
DURING TREATMENT OF AN INTRACEREBRAL ANEURYSM, THE ORBIT RDFL COMPLEX FILL COIL DETACHED AND STRETCHED IN THE MICROCATHETER WITHOUT PULLING THE DETACHMENT SYRINGE. THE PHYSICIAN WAS ABLE TO RETRIEVE THE DETACHED COIL AND MICROCATHETER CODMAN/CORDIS MICROCATHETER (CATALOG/LOT UNKNOWN) AS A UNIT WITH NO HARM TO THE PATIENT, SINCE THE PHYSICIAN HAS A LOT OF EXPERIENCE WITH THIS PRODUCT. THERE WAS NO RESISTANCE WITH THE MICROCATHETER AND DURING THE EVENT A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES. DURING DELIVERY, NO ADDITIONAL TORQUE OR MANIPULATION CONDUCTED. THE MICROCATHETER WAS NOT RE-SHAPED. ONE TO ONE BETWEEN THE COIL AND DELIVERY SYSTEM WAS VERIFY UNDER FLUOROSCOPY. OTHER THAN THE REPORTED EVENT, NO DAMAGES WERE NOTICED ON THE DELIVERY SYSTEM, OR COIL, AND THE COIL IS GOING TO BE RETURNED FOR ANALYSIS. THE MICROCATHETER IS NOT GOING TO BE RETURNED FOR ANALYSIS. THE TARGET SITE WAS STANDARD. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
THE ORBIT RDFL COMPLEX FILL COIL DETACHED WITHOUT PULLING THE DETACHMENT SYRINGE, ADDITIONALLY THE COIL PREMATURELY DETACHED IN THE MICROCATHETER DURING PLACEMENT. THE PHYSICIAN WAS ABLE TO RETRIEVE THE DETACHED COIL WITH NO HARM TO THE PATIENT, SINCE THE PHYSICIAN HAS A LOT OF EXPERIENCE WITH THIS PRODUCT. THERE WAS NO RESISTANCE WITH THE CODMAN/CORDIS MICROCATHETER, AND DURING THE EVENT A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES. OTHER THAN THE REPORTED EVENT, NO DAMAGES WERE NOTICED ON THE DELIVERY SYSTEM, OR COIL, AND THE COIL IS GOING TO BE RETURNED FOR ANALYSIS. THE TARGET SITE AND ANEURYSM WERE STANDARD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX | CNV DCS ORBIT (HCG) | HCG | CORDIS NEUROVASCULAR, INC. | NA | 15195849 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | DCS SYRINGE AND MICROCATHETER. |