ORBIT GALAXY DETACHABLE COIL SYSTEM

Report

Report Number: 3007628272-2011-50010
Event Type: Injury
Date Received: April 27, 2011
Date of Event: April 4, 2011
Report Date: April 4, 2011
Manufacturer: CODMAN AND SHURTLEFF, INC
Product Code: HCG
PMA / PMN Number: K093973
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

A NON-STERILE TRUFILL DCS ORBIT GALAXY WAS RECEIVED COILED INSIDE OF PLASTIC BAG. INTRODUCER WAS UNZIPPED AND PRESENTED NO DAMAGES. KINKS WERE NOTED IN THE HYPOTUBE. SUPPORT COIL, GRIPPER AND HEADPIECE WERE OUT OF THE INTRODUCER. NO ANOMALIES WERE NOTED IN THE SUPPORT COIL. GRIPPER PRESENTED A COMPRESSED SECTION ON THE PROXIMAL SIDE. HEADPIECE WAS STILL ATTACHED TO THE GRIPPER AND THE REST OF THE EMBOLIC COIL WAS RECEIVED SEPARATE IN A SMALL PLASTIC BAG; IT WAS UNRAVELED AND STRETCHED AND PRESENTED RESIDUES OF BLOOD. GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE AND GRIPPER PRESENTED A COMPRESSED/KINKED SECTION ON THE PROXIMAL SIDE WHILE THE EMBOLIC COIL WAS BROKEN IN DIFFERENT SECTIONS AS WELL IT WAS STRETCHED, TANGLE AND KINKED. NEITHER THE HEADPIECE NOR THE ANCHOR PRESENTED DAMAGES; HEADPIECE WAS PROPERLY ATTACHED INTO THE GRIPPER AND NO ANOMALIES WERE NOTED. 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 13500286 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. FIRST FAILURE REPORTED BY THE CUSTOMER AS COIL ENTANGLEMENT WAS CONFIRMED. SECOND FAILURE REPORTED AS PREMATURE DETACHMENT-DURING PLACEMENT WAS NOT CONFIRMED; THE CAUSE OF THE FAILURE EXPERIENCED BY THE CUSTOMER AS PREMATURE DETACHMENT WAS REALLY THAT THE EMBOLIC COIL GOT BROKEN AFTER IT WAS STRETCHED, BUT THE DETACHMENT NEVER HAPPENED DUE TO THE HEADPIECE WAS STILL ATTACHED TO THE GRIPPER. THE CAUSE OF THE DAMAGES NOTED IN THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINE; HOWEVER NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGEST THAT THESE DAMAGES COULD BE RELATED TO THE MANUFACTURING PROCESS. INSPECTIONS ARE IN PLACE THAT PREVENTS THESE KINDS OF DAMAGE LEAVING FROM THE FACILITY. IN ADDITION THE CUSTOMER DOES NOT REPORT ANY DAMAGES DURING THE INSERTION OF THE DEVICE WHICH INDICATE THAT PROCEDURAL AND HANDLING FACTORS COULD BE CONTRIBUTED IN THE DAMAGES NOTED IN THE DEVICE. THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Additional Manufacturer Narrative · 1

A NON-STERILE TRUFILL DCS ORBIT GALAXY WAS RECEIVED COILED INSIDE OF PLASTIC BAG. INTRODUCER WAS UNZIPPED AND PRESENTED NO DAMAGES. KINKS WERE NOTED IN THE HYPOTUBE. SUPPORT COIL, GRIPPER AND HEADPIECE WERE OUT OF THE INTRODUCER. NO ANOMALIES WERE NOTED IN THE SUPPORT COIL. GRIPPER PRESENTED A COMPRESSED SECTION ON THE PROXIMAL SIDE. HEADPIECE WAS STILL ATTACHED TO THE GRIPPER AND THE REST OF THE EMBOLIC COIL WAS RECEIVED SEPARATE IN A SMALL PLASTIC BAG; IT WAS UNRAVELED AND STRETCHED AND PRESENTED RESIDUES OF BLOOD. GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE AND GRIPPER PRESENTED A COMPRESSED/KINKED SECTION ON THE PROXIMAL SIDE WHILE THE EMBOLIC COIL WAS BROKEN IN DIFFERENT SECTIONS AS WELL IT WAS STRETCHED, TANGLE AND KINKED. NEITHER THE HEADPIECE NOR THE ANCHOR PRESENTED DAMAGES; HEADPIECE WAS PROPERLY ATTACHED INTO THE GRIPPER AND NO ANOMALIES WERE NOTED. 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 13500286 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. FIRST FAILURE REPORTED BY THE CUSTOMER AS "COIL ENTANGLEMENT" WAS CONFIRMED. SECOND FAILURE REPORTED AS "PREMATURE DETACHMENT-DURING PLACEMENT" WAS NOT CONFIRMED; THE CAUSE OF THE FAILURE EXPERIENCED BY THE CUSTOMER AS PREMATURE DETACHMENT WAS REALLY THAT THE EMBOLIC COIL GOT BROKEN AFTER IT WAS STRETCHED, BUT THE DETACHMENT NEVER HAPPENED DUE TO THE HEADPIECE WAS STILL ATTACHED TO THE GRIPPER. THE CAUSE OF THE DAMAGES NOTED IN THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINE; HOWEVER NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGEST THAT THESE DAMAGES COULD BE RELATED TO THE MANUFACTURING PROCESS. INSPECTIONS ARE IN PLACE THAT PREVENTS THESE KINDS OF DAMAGE LEAVING FROM THE FACILITY. IN ADDITION THE CUSTOMER DOES NOT REPORT ANY DAMAGES DURING THE INSERTION OF THE DEVICE WHICH INDICATE THAT PROCEDURAL AND HANDLING FACTORS COULD BE CONTRIBUTED IN THE DAMAGES NOTED IN THE DEVICE. THEREFORE NO CORRECTIVE ACTIONS 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 1058196-2011-00180 AND 1058196-2011-00180. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

Additional Manufacturer Narrative · 1

THE ORBIT GALAXY TIGHT DISTAL LOOP COMPLEX FILL COIL 7 X 15 COIL DETACHED FROM DELIVERY SYSTEM WHILE REPOSITIONING WHEN COILING THE SECOND 7X7 ANEURYSM. IT WAS CROSSING THE TINES OF THE ENTERPRISE STENT AND THE COIL MAY HAVE LEFT THE STENT BOUNDARIES AND GOTTEN CAUGHT IN THE STENT WHEN PULLING THE COIL BACK INTO THE MICROCATHETER. THE ENTERPRISE VRD REMAINED AT THE TARGET SITE COVERING THE ANEURYSM NECK. IT REMAINED IN THE SAME POSITION AFTER THE PROCEDURE WAS COMPLETED. ATTEMPT TO RETRIEVE THE COIL WITH AN AMPLATZ GOOSENECK MICROSNARE WAS UNSUCCESSFUL. THE COIL WAS RETRIEVED IN 3 PARTS. A LARGE ANGLE WAS PLACED ON A GUIDEWIRE WHICH WAS TORQUED TO CATCH THE STRETCHED COIL IN THE PARENT VESSEL. THIS RESULTED IN A SMALL DISSECTION IN THE INTERNAL CAROTID ARTERY (ICA) WHICH WAS TREATED WITH A PRECISE CAROTID STENT. IT WAS ORIGINALLY REPORTED THAT THE GUIDEWIRE USED TO RETRIEVE THE COIL WAS A CODMAN NEUROSCOUT; HOWEVER, AFTER RECEIPT OF A NONCORDIS GUIDEWIRE, IT WAS CLARIFIED THAT THE DEVICE THAT WAS USED TO RETRIEVE THE COIL WAS ONE OF TWO DEVICES THAT WERE IN A SALINE BOWL/BATH. THE DEVICE (GUIDEWIRE) USED TO RETRIEVE THE COIL WAS RETURNED WITH THE COIL FOR ANALYSIS. THE DEVICE RETURNED WAS CONFIRMED TO BE A NONCORDIS / NONCODMAN GUIDEWIRE; IT WAS CONFIRMED THAT THE NEUROSCOUT WAS NOT IN THE PATIENT AT THE TIME OF THE DISSECTION AND THERE WERE NO ISSUES WITH THE NEUROSCOUT. A NON-STERILE TRUFILL DCS ORBIT GALAXY WAS RECEIVED COILED INSIDE OF PLASTIC BAG. INTRODUCER WAS UNZIPPED AND PRESENTED NO DAMAGES. KINKS WERE NOTED IN THE HYPOTUBE. SUPPORT COIL, GRIPPER AND HEADPIECE WERE OUT OF THE INTRODUCER. NO ANOMALIES WERE NOTED IN THE SUPPORT COIL. GRIPPER PRESENTED A COMPRESSED SECTION ON THE PROXIMAL SIDE. HEADPIECE WAS STILL ATTACHED TO THE GRIPPER AND THE REST OF THE EMBOLIC COIL WAS RECEIVED SEPARATE IN A SMALL PLASTIC BAG; IT WAS UNRAVELED AND STRETCHED AND PRESENTED RESIDUES OF BLOOD. GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE AND GRIPPER PRESENTED A COMPRESSED/KINKED SECTION ON THE PROXIMAL SIDE WHILE THE EMBOLIC COIL WAS BROKEN IN DIFFERENT SECTIONS AS WELL IT WAS STRETCHED, TANGLED AND KINKED. NEITHER THE HEADPIECE NOR THE ANCHOR PRESENTED DAMAGES; HEADPIECE WAS PROPERLY ATTACHED INTO THE GRIPPER AND NO ANOMALIES WERE NOTED. 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 13500286 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. WITH ANALYSIS OF THE RETURNED DEVICE, THE FAILURE MODE WAS NOT A PREMATURE DETACHMENT OF THE COIL FROM THE DELIVERY SYSTEM BUT WAS FOUND TO BE A STRETCHED COIL WITH SEPARATION OF THE COIL FROM THE COIL HEAD-PIECE. THE CAUSE OF THE DAMAGES NOTED ON THE RETURNED DEVICE CANNOT BE DEFINITIVELY DETERMINED, BUT THEY APPEAR TO BE RELATED TO ENTANGLEMENT WITH THE PREVIOUSLY PLACED STENT AS WELL AS THE RETRIEVAL PROCESS APPEAR TO HAVE CONTRIBUTED. INSPECTIONS ARE IN PLACE TO PREVENT DEVICES WITH THESE DAMAGES FROM LEAVING THE FACILITY. ALTHOUGH THE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED, AS REPORTED, IT APPEARS THAT DEVICE INTERACTION CONTRIBUTED TO THE EVENT. WITH REVIEW OF THE AVAILABLE INFORMATION, THE ANALYSIS OF THE RETURNED DEVICE AND THE DEVICE HISTORY RECORDS THERE IS NO INDICATION OF A RELATIONSHIP TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCTS USED DURING THE PROCEDURE CONSISTED OF A PROWLER SELECT STRAIGHT MICROCATHETER, AN ENTERPRISE 4.5X22 STENT, A PROWLER LP SELECT 45 DEGREE MICROCATHETER, A TRUFILL DCS SYRINGE, A GALAXY XTRASOFT 2.5X2.5, A GALAXY XTRASOFT 2X1.5, A GALAXY FILL 7X15 (DEFECTIVE PRODUCT), TWO NEUROSCOUT WIRES, A TRASCEND EX SOFT WIRE, AND A PRECISE CAROTID STENT 8X30. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00180. THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

Description of Event or Problem · 1

DURING STENT/COILING PROCEDURE, THE ORBIT GALAXY TIGHT DISTAL LOOP COMPLEX FILL COIL 7 X 15 COIL DETACHED FROM PUSHER WHILE COILING THE SECOND 7X7 ANEURYSM. THE COIL DETACHED FROM PUSHER WHILE PHYSICIAN WAS REPOSITIONED THE COIL. PHYSICIAN NOTED THAT HE WAS CROSSING THE TINES OF THE ENTERPRISE STENT AND THE COIL MAY HAVE LEFT THE STENT BOUNDARIES AND GOTTEN CAUGHT IN THE STENT WHEN HE WENT TO PULL BACK INTO THE MICROCATHETER. PHYSICIAN ATTEMPTED TO RETRIEVE WITH AMPLATZ GOOSENECK MICROSNARE BUT WAS UNSUCCESSFUL. PHYSICIAN PLACED LARGE ANGLE ON NEUROSCOUT MICROWIRE (B)(4) AND TORQUED TO CATCH THE STRETCHED COIL IN THE PARENT VESSEL. THE COIL WAS RETRIEVED IN 3 PARTS AND WAS PLACED IN A BIOHAZARD BAG FOR RETURN AND ANALYSIS. A SMALL DISSECTION RESULTED IN THE ICA WHICH WAS TREATED WITH AN 8X30 PRECISE CAROTID STENT. THE DISSECTION WAS CAUSED EITHER BY THE NEUROSCOUT OR THE TRANSEND GUIDEWIRE. A CD COPY OF THE PROCEDURE IS NOT AVAILABLE. DURING THE EVENT, THE ENTERPRISE REMAINED AT THE TARGET SITE COVERING THE ANEURYSM NECK, AND REMAINED IN THE SAME POSITION AFTER THE PROCEDURE WAS COMPLETED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ORBIT GALAXY DETACHABLE COIL SYSTEM	ARTIFICIAL EMBOLIZATION DEVICE	HCG	CODMAN AND SHURTLEFF, INC	NA	13500286

Patients

Seq	Age	Sex	Outcome	Treatment
1	72 YR		Required Intervention