TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

Report

Report Number: 1058196-2011-00066
Event Type: Injury
Date Received: February 24, 2011
Date of Event: February 1, 2011
Report Date: February 3, 2011
Manufacturer: CORDIS NEUROVASCULAR, INC.
Product Code: HCG
PMA / PMN Number: K053197
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DURING A COIL EMBOLIZATION PROCEDURE, THE ORBIT RDFL COMPLEX FILL COIL ((B)(4)) PREMATURELY DETACHED. THE COIL STUCK AT TIP OF HEADWAY MICROCATHETER (MC) OR IN THE NEST OF COILS AND WHEN RETRACTED THE COIL BECAME DISENGAGED FROM THE DETACHMENT ZONE. THERE WAS FRICTION AT DISTAL TIP OF MC AS COIL WAS EXITING AND COULD NOT DETERMINE IF COIL WAS GETTING STUCK IN MC OR THERE WERE CHALLENGES TO COIL MAKING FIRST BREAKS AND WAS STUCK IN NEST OF COILS. THE HEADWAY WAS CUT AT THE HUB AND A SNARE DEVICE WAS ADVANCED OVER THE MC TO RETRIEVE BOTH COIL & MC, AND THE COIL WAS STILL IN MC. ADDITIONALLY, THE COIL SEPARATE INTO TWO PIECES WHEN PULLED FROM ANEURYSM USING THE SNARE, AND A SMALL PIECE WAS WITHIN THE ANEURYSM AND A TAIL WAS PROTRUDING INTO THE PARENT ARTERY. HOWEVER, THE PIECE THAT WAS PROTRUDING WAS INSERTED IN THE ANEURYSM. THE PRODUCTS (COIL/MC) WILL BE RETURNED FOR ANALYSIS, BUT THE DELIVERY SYSTEM WAS DISCARDED. DURING THE EVENT, THE COIL DID NOT UNRAVELED OR STRETCHED, AND DURING REPOSITIONING, THE COIL WAS UTILIZED LIKE A GUIDEWIRE (LEFT IN THE ANEURYSM SAC WHILE REPOSITIONING THE MICROCATHETER). NO ADDITIONAL TORQUE, PULLING OR MANIPULATION WAS UTILIZED AT ANY TIME THE COIL WAS BEING DELIVERED, REPOSITIONED OR WITHDRAWN. NO PRESSURE WAS APPLIED WITH THE SYRINGE TO DETACH THE COIL, AND THE SYRINGE WAS ONLY USED DURING INITIAL PREP. THE SYRINGE WAS UTILIZED WITH OTHER 3 COILS. A BALLOON REMODELING WAS NOT UTILIZED DURING THE PROCEDURE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Additional Manufacturer Narrative · 1

A NON-STERILE PART OF A NON - CORDIS MICROCATHETER WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE PRODUCT WAS INSPECTED AND ONE EMBOLIC COIL WAS FELT INSIDE ON THE DISTAL SECTION OF THE NON-CORDIS MICROCATHETER. THE TRUFILL DCS WAS NOT RECEIVED FOR ANALYSIS. THE NON CORDIS MICROCATHETER WAS CUT AT 17.5CM FROM THE DISTAL END AND THE EMBOLIC COIL WAS EXPOSED AFTER THAT THE EMBOLIC COIL WAS REMOVED FROM THE DEVICE AND IT WAS FOUND WITH RESIDUES OF DRY BLOOD IN STRETCHED CONDITION. 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 "DSC RESISTANCE/FRICTION AND COIL PREMATURE DETACHMENT" COULD NOT BE EVALUATED SINCE THE PRODUCT WAS NOT RETURNED. THE CAUSE OF THE COIL STRETCHED COULD NOT BE CONCLUSIVE DETERMINATE HOWEVER THESE DEFECTS COULD NOT BE RELATED TO THE MANUFACTURING PROCESS. 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.

Additional Manufacturer Narrative · 1

A NON-STERILE PART OF A NON - CORDIS MICROCATHETER WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE PRODUCT WAS INSPECTED AND ONE EMBOLIC COIL WAS FELT INSIDE ON THE DISTAL SECTION OF THE NON-CORDIS MICROCATHETER. THE TRUFILL DCS WAS NOT RECEIVED FOR ANALYSIS. THE NON CORDIS MICROCATHETER WAS CUT AT 17.5CM FROM THE DISTAL END AND THE EMBOLIC COIL WAS EXPOSED AFTER THAT THE EMBOLIC COIL WAS REMOVED FROM THE DEVICE AND IT WAS FOUND WITH RESIDUES OF DRY BLOOD IN STRETCHED CONDITION. DIMENSIONAL INSPECTION (ID) WAS PERFORMED IN THE RECEIVED MICROCATHETER AND IT WAS 0.0175" IN THE DISTAL TIP AND ACCORDING TO THE IFU IT IS COMPATIBLE WITH THE ORBIT PRODUCT. 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 "DSC RESISTANCE/FRICTION AND COIL PREMATURE DETACHMENT" COULD NOT BE EVALUATED SINCE THE PRODUCT WAS NOT RETURNED. THE CAUSE OF THE COIL STRETCHED COULD NOT BE CONCLUSIVE DETERMINATE, HOWEVER, THESE DEFECTS COULD NOT BE RELATED TO THE MANUFACTURING PROCESS. 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.

Additional Manufacturer Narrative · 1

DURING A COIL EMBOLIZATION PROCEDURE, THE ORBIT RDFL COMPLEX FILL COIL (B)(4) PREMATURELY DETACHED. THE COIL STUCK AT THE TIP OF HEADWAY MICROCATHETER (MC) OR IN THE NEST OF COILS AND WHEN RETRACTED THE COIL BECAME DISENGAGED FROM THE DETACHMENT ZONE. THERE WAS FRICTION AT DISTAL TIP OF MC AS COIL WAS EXITING AND IT COULD NOT BE DETERMINE IF COIL WAS GETTING STUCK IN MC OR IF IT WAS BECAUSE THERE WERE CHALLENGES TO THE COIL MAKING FIRST BREAKS AND WAS STUCK IN THE NEST OF COILS. THE HEADWAY WAS CUT AT THE HUB AND A SNARE DEVICE WAS ADVANCED OVER THE MC TO RETRIEVE BOTH COIL & MC, AND THE COIL WAS STILL IN THE MC. ADDITIONALLY, THE COIL SEPARATED INTO TWO PIECES WHEN PULLED FROM ANEURYSM USING THE SNARE, AND A SMALL PIECE WAS WITHIN THE ANEURYSM AND A TAIL WAS PROTRUDING INTO THE PARENT ARTERY. HOWEVER, THE PIECE THAT WAS PROTRUDING WAS INSERTED IN THE ANEURYSM. DURING THE EVENT, THE COIL DID NOT UNRAVELED OR STRETCH. DURING REPOSITIONING, THE COIL WAS UTILIZED LIKE A GUIDEWIRE (LEFT IN THE ANEURYSM SAC WHILE REPOSITIONING THE MICROCATHETER). NO ADDITIONAL TORQUE, PULLING OR MANIPULATION WAS UTILIZED AT ANY TIME THE COIL WAS BEING DELIVERED, REPOSITIONED OR WITHDRAWN. NO PRESSURE WAS APPLIED WITH THE SYRINGE TO DETACH THE COIL, AND THE SYRINGE WAS ONLY USED DURING INITIAL PREP. THE SYRINGE WAS UTILIZED WITH OTHER 3 COILS. A BALLOON REMODELING WAS NOT UTILIZED DURING THE PROCEDURE. THE PRODUCTS (COIL/MC) WILL BE RETURNED FOR ANALYSIS, BUT THE DELIVERY SYSTEM WAS DISCARDED. A NON-STERILE PART OF A NON - CORDIS MICROCATHETER WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE PRODUCT WAS INSPECTED AND ONE EMBOLIC COIL WAS FELT INSIDE OF THE DISTAL SECTION OF THE NON-CORDIS MICROCATHETER. THE TRUFILL DCS ORBIT DELIVERY SYSTEM WAS NOT RECEIVED FOR ANALYSIS. THE NON CORDIS MICROCATHETER WAS CUT AT 17.5CM FROM THE DISTAL END AND THE EMBOLIC COIL WAS EXPOSED AFTER THAT THE EMBOLIC COIL WAS REMOVED FROM THE DEVICE AND IT WAS FOUND WITH RESIDUES OF DRY BLOOD AND IN A STRETCHED CONDITION. DIMENSIONAL INSPECTION (ID) WAS PERFORMED IN THE RECEIVED MICROCATHETER AND IT WAS 0.0175 IN THE DISTAL TIP WHICH ACCORDING THE IFU IT IS COMPATIBLE WITH THE ORBIT PRODUCT. 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 REPORTED RESISTANCE/FRICTION WITHIN THE MICROCATHETER COULD NOT BE EVALUATED BASED ON THE RECEIVED CONDITION OF THE DEVICE. THE CAUSE OF THE STRETCHED CONDITION OF THE COIL COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, BASED ON THE INFORMATION IT APPEARS TO BE RELATED TO PROCEDURAL FACTORS AND THE REQUIRED SNARE RETRIEVAL PROCESS. THERE IS NO INDICATION OF A RELATIONSHIP TO THE MANUFACTURING PROCESS. INSPECTIONS ARE IN PLACE TO PREVENT DEVICES WITH THIS TYPE OF DAMAGE FROM LEAVING THE FACILITY. IT WAS REPORTED THAT THERE WAS RESISTANCE DURING DEPLOYMENT OF THE ORBIT COIL OUT THE DISTAL END OF THE CONCOMITANT NONCORDIS MICROCATHETER. THE INSTRUCTIONS FOR USE (IFU) CAUTIONS TO NEVER ADVANCE, WITHDRAW, OR TORQUE THE DELIVERY TUBE AGAINST RESISTANCE WITHOUT FIRST DETERMINING THE CAUSE OF THE RESISTANCE UNDER FLUOROSCOPY. THESE MANIPULATIONS OF THE DELIVERY TUBE AGAINST RESISTANCE MAY CAUSE DAMAGE AND/OR PREMATURE DETACHMENT OF THE EMBOLIC COIL. IF UNUSUAL FRICTION IS NOTED WITHIN THE INFUSION CATHETER, REMOVE THE DETACHABLE COIL UNIT. ADDITIONALLY IT WAS REPORTED THAT THE MICROCATHETER WAS REPOSITIONED OVER THE COIL. THE IFU CAUTIONS THAT REPOSITIONING THE INFUSION CATHETER WHILE THE COIL IS DEPLOYED MAY LEAD TO DAMAGE AND/OR PREMATURE DETACHMENT OF THE EMBOLIC COIL. ALTHOUGH WITHOUT THE RETURN OF THE DELIVERY SYSTEM, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE RESISTANCE BETWEEN THE ORBIT COIL SYSTEM AND THE NONCORDIS MICROCATHETER, IT APPEARS THAT DEVICE INTERACTION AND PROCEDURAL MANIPULATION CONTRIBUTED THE PREMATURE DETACHMENT OF THE COIL. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

Description of Event or Problem · 1

DURING A COIL EMBOLIZATION PROCEDURE, THE ORBIT RDFL COMPLEX FILL COIL (638CF0615) PREMATURELY DETACHED. THE COIL STUCK AT TIP OF HEADWAY MICROCATHETER (MC) OR IN THE NEST OF COILS AND WHEN RETRACTED THE COIL BECAME DISENGAGED FROM THE DETACHMENT ZONE. THERE WAS FRICTION AT DISTAL TIP OF MC AS COIL WAS EXITING AND COULD NOT DETERMINE IF COIL WAS GETTING STUCK IN MC OR THERE WERE CHALLENGES TO COIL MAKING FIRST BREAKS AND WAS STUCK IN NEST OF COILS. THE HEADWAY WAS CUT AT THE HUB AND A SNARE DEVICE WAS ADVANCED OVER THE MC TO RETRIEVE BOTH COIL AND MC, AND THE COIL WAS STILL IN MC. THE PRODUCTS (COIL/MC) WILL BE RETURNED FOR ANALYSIS, BUT THE DELIVERY SYSTEM WAS DISCARDED.

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	13471496

Patients

Seq	Age	Sex	Outcome	Treatment
1				MICROCATHETER