PRESIDIO 18 - CERECYTE MICROCOIL
Report
- Report Number
- 2954740-2012-00800
- Event Type
- Malfunction
- Date Received
- November 30, 2012
- Date of Event
- November 7, 2012
- Report Date
- November 13, 2012
- Manufacturer
- MICRUS ENDOVASCULAR, LLC
- Product Code
- HCG
- PMA / PMN Number
- K062036
- Removal / Correction Number
- 1
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
NOTE: INITIAL REPORT SUBMITTED INDICATED "SERIOUS INJURY", "TYPE OF REPORTABLE EVENT", A CORRECTION IS NOW BEING SUBMITTED TO CORRECT IT TO "MALFUNCTION". IN ADDITION, THE INITIAL REPORT DID NOT INDICATE THE LOT NUMBER OF THE DEVICE. THE LOT NUMBER IS NOW BEING REPORTED AS C12881 WITH A MANUFACTURING DATE OF 10/2012 AND EXPIRATION DATE OF 09/30/2017. THERE WAS SEVERE RESISTANCE ADVANCING THE PRESIDIO ((B)(4)) THROUGH THE EXCELSIOR 1018 MICROCATHETER. AFTER CONTINUED ADVANCEMENT THE COIL STRETCHED AND DETACHED PARTIALLY IN THE ANEURYSM AND PARTIALLY IN THE MICROCATHETER WHEN PULLING BACK FOR REMOVAL. THE ENTIRE COIL WAS SAFELY RETRIEVED FROM THE PATIENT USING THE MICROCATHETER, GUIDING CATHETER AND BALLOON CATHETER AS A UNIT. IT WAS REPORTED THAT WHEN USING ADDITIONAL FORCE TO PULL BACK THE DPU WIRE, A PART OF THE PRESIDIO MIGHT HAVE GOTTEN HUNG UP SOMEWHERE WITHIN THE MICROCATHETER, WHICH WOULD CAUSE THE COIL SEPARATION. AFTER REMOVAL, THE PROCEDURE WAS CONTINUED WITHOUT ANY FURTHER ISSUES. NO PATIENT INJURY/COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS A COIL EMBOLIZATION OF AN ANEURYSM LOCATED IN THE BIFURCATION AT THE HEPATIC ARTERY AND GASTRODUODENAL ARTERY WITH MODERATE VESSEL TORTUOSITY WITHOUT CALCIFICATION. THE PRESIDIO WAS BEING ADVANCED THROUGH THE EXCELSIOR WHICH WAS DELIVERED THROUGH A 7FR BRITE TIP GUIDE CATHETER (CATALOGUE/LOT UNKNOWN) WHEN THE SEVERE RESISTANCE WAS ENCOUNTERED. HOWEVER, THE DEVICE WAS CONTINUED TO BE ADVANCED AND SEVERE RESISTANCE WAS STILL EXPERIENCED JUST AFTER THE TIP OF THE MICROCOIL OF THE PRESIDIO REACHED INTO THE TARGET ANEURYSM. THEREFORE, THE DECISION WAS MADE TO REMOVE THE PRESIDIO FORM THE PATIENT. WHILE GENTLY PULLING BACK THE PRESIDIO, THE COIL UNRAVELED AND SEPARATED INTO THE MICROCATHETER. THE PROXIMAL SECTION OF THE COIL WAS LEFT IN THE MICROCATHETER AND REST OF THE COIL IN THE ANEURYSM. AN ATTEMPT WAS MADE TO RETRIEVE THE SEPARATED COIL AND THE MICROCATHETER AS A UNIT, BUT THE SEPARATED COIL REMAINED IN THE GUIDING CATHETER. THEN, AN UNSPECIFIED BALLOON CATHETER(HYPERGLIDE/COVIDIEN (B)(4)) WAS USED TO HOLD THE SEPARATED PRESIDIO TO THE WALL OF THE GUIDING CATHETER AND FINALLY THE ENTIRE SYSTEM INCLUDING THE ENTIRE PRESIDIO, THE MICROCATHETER, BALLOON CATHETER AND THE GUIDING CATHETER WERE REMOVED AS A UNIT FROM THE PATIENT SUCCESSFULLY. PRIOR TO THE EVENT, TWO COMPETITOR'S COILS (GDC/STRYKER, DETAIL UNKNOWN) WERE PLACED IN THE ANEURYSM USING THE SAME MICROCATHETER WITHOUT ANY DIFFICULTIES. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON THE PRODUCT BY VISUAL INSPECTION. NO OTHER DAMAGES WERE REPORTED ON THE DEVICES AFTER THE EVENT. THE COIL WAS RETURNED SEVERELY DAMAGED AND MECHANICALLY SEPARATED FROM THE DEVICE POSITIONING UNIT (DPU). THE MIDSECTION OF THE COIL HAS BEEN SEVERELY STRETCHED WITH SEVERE MULTIPLE KINKS. ONE OF THE KINKS CONTAINED A LARGE SOLID PLUG OF A BLOOD MIXTURE ADHERING TO IT. THE PROXIMAL END THE DISTAL SECTIONS OF THE COIL RETAINED THEIR SECONDARY SHAPING. LOCATED ON THE TOP PROXIMAL END OF THE RESHEATHING TOOL IN THE CUTOUT SECTION, THE V NOTCH HAS BEEN SEVERELY DAMAGED. THE V NOTCHES DAMAGED EDGE HAS BEEN RAISED ABOVE THE SURFACE PLANE. THERE IS SEVERE DAMAGE TO THE SHEATH'S LOCKING MECHANISM. THE SURFACE MATERIAL HAS BEEN DAMAGED AND STRETCHED. THERE ARE TWO POSSIBLE CONTRIBUTING FACTORS TO THE COILS SEVERE RESISTANCE INSIDE THE MICROCATHETER. THE PRIMARY CONTRIBUTING FACTOR APPEARS TO HAVE OCCURRED WHEN THE DEVICE WAS UNLOCKED FOR USE AND THE SHEATH'S PULL TAB WAS THEN RETRACTED STRAIGHT BACK INSTEAD OF UP AT A FORTY-FIVE DEGREE ANGLE AND THEN BACK. THE STRAIGHT BACK RETRACTION CAUGHT THE LOCKING MECHANISM IN THE RESHEATHING TOOL'S V NOTCH. THIS CAUSES THE SHEATH TO BECOME EMBEDDED INSIDE THE V NOTCH. THIS CAUSES A BINDING ACTION BETWEEN THE DPU, SHEATH, AND COIL WHICH SEVERELY DAMAGED THE RESHEATHING TOOL, THE SHEATH AND MAY HAVE CAUSED THE COIL TO BUCKLE. THIS WOULD HAVE PRODUCED SIGNIFICANT RESISTANCE DURING THE COILS ADVANCED THROUGH THE MICROCATHETER. IT IS POSSIBLE THAT IF THE COIL WAS BUCKLED DURING THIS EVENT, IT WOULD HAVE ANCHORED THE COIL CAUSING THE COIL TO STRETCH DURING THE REMOVAL PROCESS. HOWEVER, IT IS MORE LIKELY THAT THE COIL MAY HAVE BEEN ANCHORED INSIDE THE ANEURYSM ON ITSELF, THE COILS ALREADY DWELLING INSIDE, OR ON THE DISTAL TIP OF THE MICROCATHETER WHICH WOULD CAUSE THE COIL TO STRETCH DURING REPOSITIONING OR REMOVAL. IT WAS REPORTED THAT SEVERE RESISTANCE WAS ENCOUNTERED DURING THE COILS ADVANCEMENT; HOWEVER IT WAS DECIDED TO KEEP ADVANCING THE COIL. FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE (IFU) OUTLINES THE FOLLOWING, 'HOLD THE INTRODUCER SHEATH (LOOSELY-LOOPED) IN THE LEFT HAND. KEEPING THE INTRODUCER TIP NEAR THE RE-SHEATHING TOOL, GRASP THE DISTAL END OF THE RE-SHEATHING TOOL BETWEEN YOUR LEFT THUMB AND FOREFINGER. GRASP THE CLEAR TAB NEAR THE END OF THE INTRODUCER SHEATH BODY WITH THE THUMB AND FOREFINGER OF YOUR OTHER HAND. GENTLY PULL THE CLEAR TAB OF THE INTRODUCER SHEATH OUT AND AWAY FROM THE RE SHEATHING TOOL AT A 45-DEGREE ANGLE TO UNLOCK THE MICROCOIL. CONTINUE TO PULL THE TAB UNTIL AN ADDITIONAL 0.5 TO 1.0 INCHES (1.3 TO 2.5 CM) OF THE TRANSLUCENT MATERIAL IS EXPOSED. GENTLY FOLD THE TRANSLUCENT TAB TOWARDS THE DISTAL END, AND FIRMLY GRASP THE DISTAL END OF THE RE SHEATHING TOOL AND THE TRANSLUCENT TAB BETWEEN YOUR THUMB AND FOREFINGER' THIS IS FURTHER SHOWN DIAGRAMMATICALLY. ADDITIONALLY THE IFU CAUTIONS THAT IF UNUSUAL FRICTION IS NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM, VERIFY THE LOCKING MECHANISM, OR CLEAR TAB IS UNLOCKED AND PULLED OUT FROM THE RESHEATHING TOOL APPROXIMATELY 1IN. (2-3CM). CAUTION: IF REPOSITIONING OF THE MICROCOIL IS NECESSARY, CAREFULLY OBSERVE THE MOTION OF THE MICROCOIL IN RESPECT TO THE DPU WIRE WHILE RETRACTING THE MICROCOIL UNDER FLUOROSCOPY. IF THE MICROCOIL MOVEMENT IS NOT ONE-TO-ONE WITH THE DPU WIRE, OR IF REPOSITIONING IS DIFFICULT, THE MICROCOIL MAY HAVE BECOME STRETCHED AND COULD POSSIBLY BREAK. GENTLY REMOVE AND DISCARD THE MICROCOIL SYSTEM. THE IFU FURTHER CAUTIONS THAT IF THE MICROCOIL IS POSITIONED AT A RELATIVE SHARP ANGLE TO THE MICROCATHETER, A MICROCOIL MAY STRETCH OR BREAK AS IT IS BEING WITHDRAWN. BY REPOSITIONING THE DISTAL TIP OF THE CATHETER AT OR SLIGHTLY INSIDE THE OSTIUM OF THE ANEURYSM, THE MICROCOIL MAY BE MORE EASILY FUNNELED BACK INTO THE MICROCATHETER.' IN ADDITION TO THIS LIKELY PRIMARY CONTRIBUTING FACTOR, DISTAL INTERFERENCE INSIDE THE MICROCATHETER MAY HAVE PRODUCED ADDITIONAL RESISTANCE TO THE COIL DURING ADVANCEMENT AND THE EVENTUAL STRETCHING DURING REMOVAL. THE SOURCE OF THIS INTERFERENCE, WHETHER OF A FIXED OR DETACHED NATURE, CANNOT BE DETERMINED. IT IS POSSIBLE THAT THE BLOOD PLUGS FOUND ADHERING TO THE KINKED COIL CONTRIBUTED TO THE RESISTANCE AND THE SUBSEQUENT EVENTS. FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE IFU RECOMMENDS CAUTIONS THAT IF UNUSUAL FRICTION IS STILL NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM, VERIFY FLUSH LINES ARE OPEN AND PROPERLY PRESSURIZED. THEN SLOWLY WITHDRAW THE ENTIRE MICRUS MICROCOIL SYSTEM AND EXAMINE FOR DAMAGE. REPLACE IT WITH A NEW MICROCOIL SYSTEM. IF FRICTION STILL EXISTS, WITHDRAW AND EXAMINE THE DELIVERY CATHETER SYSTEM. IN ADDITION, WITHOUT THE RETURN OF THE EXCELSIOR 1018 MICROCATHETER USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THIS COMPONENT HAD ANY ADDITIONAL CONTRIBUTIONS TO THE COMPLAINT EVENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. WITH REVIEW OF THE REPORTED INFORMATION AND THE ANALYSIS OF THE RETURNED EVENT, IT APPEARS THAT PROCEDURAL FACTORS ADDRESSED IN THE IFU INCLUDING THE UNSHEATHING TECHNIQUE, CONTINUED ADVANCEMENT OF THE DEVICE IN THE PRESENCE OF RESISTANCE AND POSSIBLY AN INADEQUATE FLUSH CONTRIBUTED TO THE EVENTS. THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING ISSUES RELATED TO THE EVENT; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
EVENT DESCRIPTION: THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON THE PRODUCT BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICES AFTER THE EVENT. THERE WAS NO STRETCHING OR UNINTENDED DETACHMENT OBSERVED IN THE MICROCATHETER. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. THE COMPLAINT PRODUCT IS GOING TO BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE. CONCOMITANT DEVICES: UNKNOWN EXCELSIOR1018 (STRYKER) MICROCATHETER; UNKNOWN 7FRENCH BRITE TIP; UNKNOWN HYPERGLYDE BALLOON CATHETER; UNKNOWN GDC COILS. THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
THE PROCEDURE WAS COIL EMBOLIZATION FOR ANEURYSM LOCATED IN BIFURCATION AT HEPATIC ARTERY AND GASTRODUODENAL ARTERY THAT WAS MODERATELY TORTUOUS AND NOT CALCIFIED. DURING THE PROCEDURE, WHILE ADVANCING A PRESIDIO ((B)(4), COMPLAINT PRODUCT) IN AN UNSPECIFIED EXCELSIOR1018 (STRYKER) WHICH DELIVERED THROUGH A 7FR BRITE TIP (CATALOGUE/LOT UNKNOWN), THE PHYSICIAN EXPERIENCED SEVERE RESISTANCE. HOWEVER, HE CONTINUED TO ADVANCE, AND HE STILL EXPERIENCED SEVERE RESISTANCE JUST AFTER THE TIP OF THE MICROCOIL OF THE PRESIDIO REACHED IN THE TARGET ANEURYSM. THUS, HE DECIDED TO REMOVE THE PRESIDIO FROM THE PATIENT. WHILE HE WAS GENTLY PULLING BACK THE PRESIDIO, THE COIL WAS UNLABELED AND SEPARATED IN THE MICROCATHETER. THE PROXIMAL SECTION OF THE COIL WAS LEFT IN THE MICROCATHETER AND REST OF THE COIL IN THE ANEURYSM. SO THE PHYSICIAN TRIED TO RETRIEVE THE SEPARATED COIL AND THE MICROCATHETER AS A UNIT, BUT THE SEPARATED COIL REMAINED IN THE GUIDING CATHETER. THEN, AN UNSPECIFIED BALLOON CATHETER (HYPERGLIDE/COVIDIEN (B)(4)) WAS USED TO HOLD THE SEPARATED PRESIDIO TO THE WALL OF THE GUIDING CATHETER AND FINALLY ALL THE SYSTEM INCLUDING THE ENTIRE PRESIDIO, THE MICROCATHETER, BALLOON CATHETER AND THE GUIDING CATHETER WERE REMOVED AS A UNIT FROM THE PATIENT SUCCESSFULLY. ACCORDING TO THE PHYSICIAN, WHEN HE PUT ADDITIONAL FORCE TO PULL BACK THE DPU WIRE, A PART OF THE PRESIDIO MIGHT GET HUNG UP SOMEWHERE WITHIN THE MICROCATHETER, WHICH WOULD CAUSE THE COIL SEPARATION. PRIOR TO THE COMPLAINT PRODUCT, TWO COMPETITOR'S COILS (GDC/STRYKER, DETAIL UNKNOWN) WERE PLACED IN THE ANEURYSM USING THE SAME MICROCATHETER WITHOUT ANY DIFFICULTIES. AFTERWARDS, THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER ISSUES. NO PATIENT INJURY/COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRESIDIO 18 - CERECYTE MICROCOIL | CNV DCS COILS | HCG | MICRUS ENDOVASCULAR, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |