AZUR-35 DETACHABLE HYDRO
Report
- Report Number
- 2032493-2023-01092
- Event Type
- Malfunction
- Date Received
- December 5, 2023
- Date of Event
- November 16, 2023
- Report Date
- February 22, 2024
- Manufacturer
- MICROVENTION, INC.
- Product Code
- KRD
- PMA / PMN Number
- K093002
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE DEVICE WAS RETURNED TO THE MANUFACTURER AND ITS EVALUATION WAS COMPLETED. INVESTIGATION FINDINGS: ITEMS RETURNED FOR EVALUATION: PUSHER; IMPLANT. ITEMS NOT RETURNED FOR EVALUATION: INTRODUCER; SHRINK LOCK; DISPENSER HOOP; CATHETER; V-GRIP. THE VISUAL ANALYSIS OF THE RETURNED ITEMS FOUND THE PUSHER STRAIN RELIEF DAMAGED, AND THE IMPLANT NOT ATTACHED TO THE PUSHER, BUT NO INDICATION OF CONTROLLER ACTIVATION WAS OBSERVED ON THE PUSHER HEATER COIL. THE IMPLANT WAS RETURNED DAMAGED, DEFORMED AND SEPARATED FROM THE PUSHER. INVESTIGATION OF THE PUSHER FOUND THE MONOFILAMENT BROKEN, WHICH INDICATES THE DEVICE EXPERIENCED A TENSILE BREAK. INVESTIGATION CONCLUSION: THE INVESTIGATION OF THE RETURNED COIL SYSTEM FOUND THE PUSHER STRAIN RELIEF DAMAGED, AND THE IMPLANT DAMAGED, DEFORMED, AND SEPARATED FROM THE PUSHER; HOWEVER, NO INDICATIONS OF ACTIVATION USING A DETACHMENT CONTROLLER WAS FOUND ON THE PUSHER HEATER COIL. THE INVESTIGATION FOUND THE PUSHER'S MONOFILAMENT WITH A TENSILE BREAK SHAPE AT THE TIP, WHICH IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCE THAT EXCEEDED THE STRENGTH OF THE MONOFILAMENT CAUSING THE IMPLANT TO SEPARATE FROM THE PUSHER. THE PHYSICAL EVALUATION OF THE DEVICE COULD NOT IDENTIFY THE CONDITIONS OR CIRCUMSTANCES THAT LED TO THE DAMAGE, BUT THE DAMAGE IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCES OVER SPECIFICATION. THE CATHETER USED IN THE PROCEDURE WAS NOT RETURNED FOR EVALUATION, SO THE INVESTIGATION COULD NOT DETERMINE IF IT HAD CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT.
ADDITIONAL INFORMATION AND DEVICE NOT RECEIVED BY MANUFACTURER DESPITE MULTIPLE ATTEMPTED REQUESTS. ADDITIONAL INFORMATION: H10 (SUMMARY OF INVESTIGATION). SUMMARY OF INVESTIGATION: VISUAL ANALYSIS: A VISUAL INSPECTION OF THE DEVICE CAPTURED IN THIS FILE COULD NOT BE PERFORMED AS A PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION, NOR WERE ANY IMAGES OF THE DEVICE PROVIDED IN PLACE OF A DEVICE RETURN. PROCEDURE AND MEDICAL IMAGING WAS NOT PROVIDED FOR THIS INVESTIGATION. INVESTIGATION FINDINGS: WITHOUT THE RETURN AND PHYSICAL EVALUATION OF THE DEVICE, THE INVESTIGATION CANNOT DEFINITIVELY DETERMINE IF A CONDITION EXISTED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WITHOUT IMAGING, THE INVESTIGATION CANNOT VERIFY THE EVENT OCCURRED AS DESCRIBED, NOR COULD THE INVESTIGATION DEFINITIVELY DETERMINE THE CAUSE OF THE REPORTED EVENT. BASED ON A REVIEW OF THE DEVICE¿S RISK DOCUMENTATION, THE REPORTED EVENT DID NOT INDICATE THERE WERE ANY POTENTIAL OR NEW MANUFACTURING, DESIGN, QUALITY, OR OTHER SYSTEMIC ISSUES, OR NON-CONFORMANCES. THE COMPLAINT CODE IS MONITORED THROUGH THE TRENDING PROCESS; CORRECTIVE ACTION IS DETERMINED, AS NEEDED, THROUGH THIS PROCESS. INVESTIGATIONS OF HISTORIC COMPLAINT FILES WITH SIMILAR COMPLAINT CATEGORY CODING ARE RECORDED IN THE COMPLAINT HANDLING SYSTEM; WITHOUT THE ABILITY TO PERFORM AND ANALYSIS OF THE DEVICE, THIS INVESTIGATION CANNOT IDENTIFY WITH CERTAINTY ANY POTENTIAL ROOT CAUSES. BATCH REVIEW: A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. COMPLAINT SYSTEM REVIEW: THERE ARE NO SIMILAR COMPLAINTS BASED ON THE COMPLAINT CATEGORY REGARDING THIS BATCH NUMBER FROM THE LAST TWO YEARS RECORDED IN THE COMPLAINT SYSTEM AT THE TIME OF THIS INVESTIGATION. IFU REVIEW (ADDITIONAL INFORMATION CAN BE FOUND IN THE IFU): POTENTIAL COMPLICATIONS POTENTIAL COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: HEMATOMA AT THE SITE OF ENTRY, VESSEL/ANEURYSM PERFORATION, UNINTENDED PARENT ARTERY OCCLUSION, INCOMPLETE FILLING, VASCULAR THROMBOSIS, HEMORRHAGE, ISCHEMIA, VASOSPASM, EDEMA, COIL MIGRATION OR MISPLACEMENT, PREMATURE OR DIFFICULT COIL DETACHMENT, CLOT FORMATION, REVASCULARIZATION, POST-EMBOLIZATION SYNDROME, AND NEUROLOGICAL DEFICITS INCLUDING STROKE AND POSSIBLY DEATH. THE PHYSICIAN SHOULD BE AWARE OF THESE COMPLICATIONS AND INSTRUCT PATIENTS WHEN INDICATED. APPROPRIATE PATIENT MANAGEMENT SHOULD BE CONSIDERED. WARNINGS AND PRECAUTIONS ¿ THIS DEVICE IS INTENDED FOR SINGLE USE ONLY. DO NOT REUSE, REPROCESS OR RESTERILIZE. REUSE, REPROCESSING OR RESTERILIZATION MAY COMPROMISE THE STRUCTURAL INTEGRITY OF THE DEVICE AND/OR LEAD TO DEVICE FAILURE WHICH, IN TURN, MAY RESULT IN PATIENT INJURY, ILLNESS, OR DEATH. REUSE, REPROCESSING, OR RESTERILIZATION MAY ALSO CREATE A RISK OF CONTAMINATION OF THE DEVICE AND/OR CAUSE PATIENT INFECTION OR CROSS-INFECTION, INCLUDING, BUT NOT LIMITED TO, THE TRANSMISSION OF INFECTIOUS DISEASE(S) FROM ONE PATIENT TO ANOTHER. CONTAMINATION OF THE DEVICE MAY LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT. ¿ ADVANCE AND RETRACT THE AZUR SYSTEM SLOWLY AND SMOOTHLY. REMOVE THE ENTIRE AZUR SYSTEM IF EXCESSIVE FRICTION IS NOTED. IF EXCESSIVE FRICTION IS NOTED WITH A SECOND AZUR SYSTEM, CHECK THE MICROCATHETER FOR DAMAGE OR KINKING. ¿ DUE TO THE DELICATE NATURE OF THE COILS, THE TORTUOUS VASCULAR PATHWAYS THAT LEAD TO CERTAIN LESIONS, AND THE VARYING MORPHOLOGIES OF THE VASCULATURE, A COIL MAY OCCASIONALLY STRETCH WHILE BEING MANEUVERED. STRETCHING IS A PRECURSOR TO POTENTIAL COIL BREAKAGE AND MIGRATION. ¿ IF REPOSITIONING IS NECESSARY, TAKE SPECIAL CARE TO RETRACT THE COIL UNDER FLUOROSCOPY IN A ONE-TO-ONE MOTION WITH THE DELIVERY PUSHER. IF THE COIL DOES NOT MOVE IN A ONE-TO-ONE MOTION WITH THE DELIVERY PUSHER, OR IF REPOSITIONING IS DIFFICULT, THE COIL MAY HAVE BECOME STRETCHED AND COULD POSSIBLY BREAK. GENTLY REMOVE AND DISCARD THE ENTIRE DEVICE. INTRODUCTION AND DEPLOYMENT OF THE AZUR SYSTEM 22. SEAT THE DISTAL TIP OF THE INTRODUCER SHEATH AT THE DISTAL END OF THE MICROCATHETER HUB AND CLOSE THE RHV LIGHTLY AROUND THE INTRODUCER SHEATH TO SECURE THE RHV TO THE INTRODUCER. DO NOT OVER-TIGHTEN THE RHV AROUND THE INTRODUCER SHEATH. EXCESSIVE TIGHTENING COULD DAMAGE THE DEVICE. 23. PUSH THE COIL INTO THE LUMEN OF THE MICROCATHETER. USE CAUTION TO AVOID CATCHING THE COIL ON THE JUNCTION BETWEEN THE INTRODUCER SHEATH AND THE HUB OF THE MICROCATHETER. INITIATE TIMING USING A STOPWATCH OR TIMER AT THE MOMENT THE DEVICE ENTERS THE MICROCATHETER. DETACHMENT MUST OCCUR WITHIN THE SPECIFIED REPOSITION TIME. 24. PUSH THE AZUR SYSTEM THROUGH THE MICROCATHETER UNTIL THE PROXIMAL END OF THE DELIVERY PUSHER MEETS THE PROXIMAL END OF THE INTRODUCER SHEATH. LOOSEN THE RHV. RETRACT THE INTRODUCER SHEATH JUST OUT OF THE RHV. CLOSE THE RHV AROUND THE DELIVERY PUSHER. SLIDE THE INTRODUCER SHEATH COMPLETELY OFF OF THE DELIVERY PUSHER. USE CARE NOT TO KINK THE DELIVERY SYSTEM. TO PREVENT PREMATURE HYDRATION OF THE AZUR SYSTEM, ENSURE THAT THERE IS FLOW FROM THE SALINE FLUSH. 27. UNDER FLUOROSCOPIC GUIDANCE, SLOWLY ADVANCE THE COIL OUT THE TIP OF THE MICROCATHETER. CONTINUE TO ADVANCE THE COIL INTO THE LESION UNTIL OPTIMAL DEPLOYMENT IS ACHIEVED. REPOSITION IF NECESSARY. IF THE COIL SIZE IS NOT SUITABLE, REMOVE AND REPLACE WITH ANOTHER DEVICE. IF UNDESIRABLE MOVEMENT OF THE COIL IS OBSERVED UNDER FLUOROSCOPY FOLLOWING PLACEMENT AND PRIOR TO DETACHMENT, REMOVE THE COIL AND REPLACE WITH ANOTHER MORE APPROPRIATELY SIZED COIL. MOVEMENT OF THE COIL MAY INDICATE THAT THE COIL COULD MIGRATE ONCE IT IS DETACHED. DO NOT ROTATE THE DELIVERY PUSHER DURING OR AFTER DELIVERY OF THE COIL INTO THE VASCULATURE. ROTATING THE DELIVERY PUSHER MAY RESULT IN A STRETCHED COIL OR PREMATURE DETACHMENT OF THE COIL FROM THE DELIVERY PUSHER, WHICH COULD RESULT IN COIL MIGRATION. ANGIOGRAPHIC ASSESSMENT SHOULD ALSO BE PERFORMED PRIOR TO DETACHMENT TO ENSURE THAT THE COIL MASS IS NOT PROTRUDING INTO UNDESIRED VASCULATURE. 28. COMPLETE THE DEPLOYMENT AND ANY REPOSITIONING SO THAT THE COIL WILL BE DETACHED WITHIN THE REPOSITION TIME SPECIFIED IN TABLE 1. AFTER THE SPECIFIED TIME, THE SWELLING OF THE HYDROPHILIC POLYMER MAY PREVENT PASSAGE THROUGH THE MICROCATHETER AND DAMAGE THE COIL. IF THE COIL CANNOT BE PROPERLY POSITIONED AND DETACHED WITHIN THE SPECIFIED TIME, SIMULTANEOUSLY REMOVE THE DEVICE AND THE MICROCATHETER. INVESTIGATION CONCLUSION: THE PHYSICAL DEVICE WAS NOT AVAILABLE FOR EVALUATION TO DETERMINE IF A CONDITION EXISTED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO EVENT. SUPPLEMENTAL IMAGING WAS ALSO UNAVAILABLE FOR REVIEW; WITHOUT IMAGING, THE INVESTIGATION CANNOT VERIFY THE EVENT OCCURRED AS DESCRIBED, NOR COULD THE INVESTIGATION DEFINITIVELY DETERMINE THE CAUSE OF THE REPORTED EVENT. THIS INFORMATION MAY BE UPDATED IF ADDITIONAL INFORMATION IS PROVIDED AT A LATER DATE.
A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THE REPORTED PART AND LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE WAS REPORTED AVAILABLE FOR RETURN BUT HAS NOT YET BEEN RECEIVED. THEREFORE, AT THIS TIME, THE PRODUCT ANALYSIS COULD NOT BE PERFORMED AND THE ALLEGED PRODUCT ISSUE CANNOT BE VERIFIED. IF THE DEVICE OR ADDITIONAL NEW INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES PREMATURE OR DIFFICULT COIL DETACHMENT AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.
IT WAS REPORTED THAT THE COIL DETACHED WITHOUT RELEASE IN THE WRONG PLACE DURING THE PROCEDURE, THEN RECOVERED AND WAS REPLACED WITH OTHER DEVICE. NO REPORT OF HARM OR INJURY TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2029725 | AZUR-35 DETACHABLE HYDRO | VASCULAR EMBOLIZATION DEVICE | KRD | MICROVENTION, INC. | 45-451230 | 0000327087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |