TRUFILL DCS ORBIT MINI COMPLEX FILL

Report

Report Number: 1058196-2011-00300
Event Type: Malfunction
Date Received: June 16, 2011
Date of Event: May 24, 2011
Report Date: May 25, 2011
Manufacturer: CORDIS NEUROVASCULAR, INC.
Product Code: HCG
PMA / PMN Number: K053197
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DURING A COIL EMBOLIZATION PROCEDURE OF AN ACOM ANEURYSM, THE ORBIT COMPLEX FILL 5X15 COIL (B)(4) HAD A BIT OF RESISTANCE WHEN ATTEMPTING TO REMOVE FROM THE ANEURYSM, AND THE COIL STRETCHED AS IT WAS BEING REPOSITIONED AND HAD TO WITHDRAWN. THE COIL WAS RETRIEVED THE COIL AND IT WAS COMPLETED BY USING ANOTHER ORBIT COIL (B)(4). THE ANEURYSM WAS SLIGHTLY WIDE NECKED AND A HYPERGLIDE BALLOON FROM EV3 WAS USED DURING THE CASE, HOWEVER DURING THE EVENT, THE BALLOON WAS NOT INFLATED. DURING REPOSITIONING, THE COIL WAS NOT LEFT IN THE ANEURYSM, WHILE THE MICROCATHETER WAS REPOSITIONED. NO RESISTANCE WAS NOTED BETWEEN THE ENV 3, ECHELON 10 MICROCATHETER, AND COIL SYSTEM. THE SAME MICROCATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE. THE MC WAS NOT RE-SHAPED PRIOR TO USE. THE VESSEL WAS TORTUROUS, AND THE SIDEWALL ANEURYSM MEASURED 11X10X7, NECK WAS 5, AND THE NECK TO SAC RATIO WAS 8. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS.

Additional Manufacturer Narrative · 1

THE COMPLAINT RECEIVED STATES THAT DURING A CEREBRAL ANEURYSM COIL EMBOLIZATION PROCEDURE THE ORBIT COMPLEX FILL COIL HAD RESISTANCE/FRICTION AND UNRAVELED/STRETCHED. THIS IS A (B)(6) FEMALE WITH MEDICAL HISTORY INCLUDING CEREBRAL ANEURYSM. THE TARGET LESION WAS AN ACOM ANEURYSM DESCRIBED AS TORTUROUS AND THE SIDEWALL ANEURYSM MEASURED 11X10X7, NECK WAS 5, AND THE NECK TO SAC RATIO WAS 8 DURING A COIL EMBOLIZATION PROCEDURE OF AN ACOM ANEURYSM, THE ORBIT COMPLEX FILL 5X15 COIL ((B)(4)) HAD A BIT OF RESISTANCE WHEN ATTEMPTING TO REMOVE FROM THE ANEURYSM, AND THE COIL STRETCHED AS IT WAS BEING REPOSITIONED AND HAD TO WITHDRAWN. THE COIL WAS RETRIEVED THE COIL AND IT WAS COMPLETED BY USING ANOTHER ORBIT COIL ((B)(4)). THE ANEURYSM WAS SLIGHTLY WIDE NECKED AND A HYPERGLIDE BALLOON FROM EV3 WAS USED DURING THE CASE, HOWEVER DURING THE EVENT, THE BALLOON WAS NOT INFLATED. DURING REPOSITIONING, THE COIL WAS NOT LEFT IN THE ANEURYSM, WHILE THE MICROCATHETER WAS REPOSITIONED. NO RESISTANCE WAS NOTED BETWEEN THE ENV 3, ECHELON 10 MICROCATHETER, AND COIL SYSTEM. THE SAME MICROCATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE. THE MC WAS NOT RE-SHAPED PRIOR TO USE. A NON-STERILE TRUFILL ORBIT DCS WAS RECEIVED COILED INSIDE OF PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND IT WAS FOUND KINKED. THE INTRODUCER WAS FOUND PARTIALLY ZIPPED AND IT WAS STUCK WITH THE GRIPPER. PART OF THE GRIPPER AND SUPPORT COIL WAS FOUND OUTSIDE OF THE INTRODUCER THE REST OF THE GRIPPER AND THE EMBOLIC COIL WERE FOUND INSIDE OF THE INTRODUCER. THE SUPPORT COIL WAS FOUND WITHOUT DAMAGE. THE GRIPPER WAS FOUND STUCK WITH THE ZIPPER AND IT PRESENTED A FLAT SECTION. THE EMBOLIC COIL WAS FOUND STRETCHED AND IT WAS STILL ATTACHED TO THE GRIPPER. THE EMBOLIC COIL AND GRIPPER WERE INSPECTED UNDER MICROSCOPE, THE GRIPPER WAS FOUND STUCK WITH THE INTRODUCER AND FLAT SECTION WAS FOUND ON IT. THE EMBOLIC COIL WAS FOUND STRETCHED. THE OD FROM THE DELIVERY TUBE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE CONDITIONS OF THE RECEIVED UNIT. 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 FAILURE REPORTED BY THE CUSTOMER AS "RESISTANCE/FRICTION DURING ADVANCEMENT" COULD NOT BE EVALUATED DUE THE CONDITIONS OF THE RECEIVED PRODUCT. THE FAILURE REPORTED BY THE COSTUMER AS "COIL - UNRAVELED STRETCHED" WAS CONFIRMED. THE CAUSE OF THE KINKS FOUND ON THE HYPOTUBE AND THE STRETCHED COIL NOT BE CONCLUSIVE DETERMINATE; HOWEVER THESE DEFECTS COULD NOT BE RELATED TO THE MANUFACTURING PROCESS AND PROCEDURAL FACTORS APPEAR TO HAVE CONTRIBUTED TO HAVE THESE DAMAGES. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED COULD BE RELATED TO THE MANUFACTURING PROCESS. ADDITIONALLY INSPECTIONS ARE IN PLACE THAT PREVENTS THIS KIND OF FAILURES LEAVING FROM THE FACILITY. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THE FAILURE REPORTED BY THE COSTUMER AS "RESISTANCE/FRICTION DURING ADVANCEMENT" COULD NOT BE EVALUATED DUE THE CONDITIONS OF THE RECEIVED PRODUCT. THE FAILURE REPORTED BY THE CUSTOMER AS "COIL - UNRAVELED STRETCHED" WAS CONFIRMED. THE CAUSE OF THE KINKS FOUND ON THE HYPOTUBE AND THE STRETCHED COIL NOT BE CONCLUSIVE DETERMINATE; HOWEVER THESE DEFECTS COULD NOT BE RELATED TO THE MANUFACTURING PROCESS AND PROCEDURAL FACTORS APPEAR TO HAVE CONTRIBUTED TO HAVE THESE DAMAGES. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED COULD BE RELATED TO THE MANUFACTURING PROCESS. ADDITIONALLY INSPECTIONS ARE IN PLACE THAT PREVENTS THIS KIND OF FAILURES LEAVING FROM THE FACILITY. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED AND CONFIRMED EVENTS.

Description of Event or Problem · 1

DURING A COIL EMBOLIZATION PROCEDURE OF AN ACOM ANEURYSM, THE ORBIT COMPLEX FILL 5X15 COIL (B)(4) HAD A BIT OF RESISTANCE WHEN ATTEMPTING TO REMOVE FROM THE ANEURYSM, AND THE COIL STRETCHED AS IT WAS BEING REPOSITIONED AND HAD TO WITHDRAWN. THE COIL WAS RETRIEVED THE COIL AND IT WAS COMPLETED BY USING ANOTHER ORBIT COIL (B)(4). THE ANEURYSM WAS SLIGHTLY WIDE NECKED AND A HYPERGLIDE BALLOON FROM EV3 WAS USED DURING THE CASE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TRUFILL DCS ORBIT MINI COMPLEX FILL	CNV DCS ORBIT (HCG)	HCG	CORDIS NEUROVASCULAR, INC.	NA	15149942

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR			HYPERGLIDE BALLOON