AZUR SOFT3D DETACHABLE 10
Report
- Report Number
- 2032493-2024-00784
- Event Type
- Malfunction
- Date Received
- October 29, 2024
- Date of Event
- October 3, 2024
- Report Date
- October 29, 2024
- Manufacturer
- MICROVENTION INC
- Product Code
- KRD
- UDI-DI
- 04987892128394
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE PRODUCT REPORTED IN THIS REPORT IS AN EXPORTED DEVICE NOT CLEARED OR APPROVED FOR MARKETING IN THE U. S. AT THE TIME OF THIS REPORTING. THE COMPLAINT IS BEING REPORTED BASED ON THIS PRODUCT MEETING SIMILAR PRODUCT CRITERIA (SIMILAR TO V-TRAK HYDROSOFT 3D, 510(K): K161367). INVESTIGATION FINDINGS: ITEMS RETURNED: N/A. 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 AN 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): PLEASE REFER TO THE JAPANESE IFU FOR PRECAUTIONS, WARNINGS, AND FURTHER INFORMATION. THE FOLLOWING IS TAKEN FROM THE ENGLISH VERSION: 4. PREPARATION OF THE COIL SYSTEM FOR DELIVERY: 4-1 REMOVE THE DETACHMENT CONTROLLER FROM ITS PROTECTIVE PACKAGING. THE DETACHMENT CONTROLLER IS PACKAGED SEPARATELY AS A STERILE DEVICE 4-2 FLUSH THE DEVICE IN ADVANCE WITH HEPARINIZED SALINE SOLUTION BY FOLLOWING THE STEPS BELOW. (1) REMOVE THE DISPENSER TUBE FROM THE PACKAGING. (2) FLUSH THE DISPENSER TUBE WITH A MINIMUM OF 3 ML OF HEPARINIZED SALINE SOLUTION FROM THE DISPENSER HUB BY SYRINGE TO THOROUGHLY WET THE DISTAL SURFACE OF THE DEVICE. (3) SLOWLY REMOVE THE PROXIMAL END OF THE DEVICE FROM THE DISPENSER TUBE. CAUTION·IF EXCESSIVE FRICTION IS NOTED DURING OPERATION, FLUSH AGAIN WITH HEPARINIZED SALINE SOLUTION AND THOROUGHLY WET THE SURFACE WITHOUT FORCING IT OUT BEFORE REMOVING IT. 4-3 FIRMLY INSERT THE PROXIMAL END OF THE PUSHER CATHETER INTO THE FUNNEL SECTION OF THE DETACHMENT CONTROLLER. AT THIS TIME, CONFIRM THAT THE BUZZER OF THE DETACHMENT CONTROLLER SOUNDS AND THE GREEN LIGHT STAYS ON FOR 3 SECONDS, AND THEN REMOVE THE PROXIMAL END OF THE PUSHER FROM THE DETACHMENT CONTROLLER. CAUTION·IF THE GREEN LIGHT DOES NOT APPEAR OR IF A RED LIGHT APPEARS, REPLACE THE DEVICE. IF THE LIGHT TURNS GREEN, THEN TURNS OFF AT ANY TIME DURING THE THREE-SECOND OBSERVATION, REPLACE THE DEVICE. 4-6 SLOWLY ADVANCE THE COIL OUT OF THE INTRODUCER SHEATH AND INSPECT THE COIL FOR ANY IRREGULARITIES OR DAMAGE. CAUTION·IF ANY DAMAGE TO THE COIL OR PUSHER CATHETER IS OBSERVED, REPLACE IT TO THE NEW COIL DELIVERY SYSTEM. IF THE DAMAGED COIL IS USED, IT CAN DAMAGE BLOOD VESSELS DURING COIL PLACEMENT/DETACHMENT AND/OR UNDESIRABLE MOVEMENT OF THE COIL IS OBSERVED. 4-7 WITH THE DISTAL END OF THE INTRODUCER SHEATH POINTED DOWNWARD, GENTLY RETRACT THE IMPLANT BACK COMPLETELY INTO THE INTRODUCER SHEATH ABOUT 1 TO 2 CM. CAUTION·IF NOT RETRACT SLOWLY, THE COIL MAY STRETCH, KNOT, DAMAGE OR BREAK. 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.
IT WAS REPORTED DURING EMBOLIZATION OF THE LA IN EVAR, THE COIL WAS USED AS THE SECOND COIL TO EMBOLIZE THE LA. DURING POSITIONING OF THE COIL AS AN ANCHOR COIL, THE IMPLANT WAS UNINTENTIONALLY DETACHED. AS THE IMPLANT WAS DETACHED IN A MICROCATHETER, THE COIL WAS WITHDRAWN WITH THE MICROCATHETER AND REMOVED FROM THE PATIENT. ANOTHER COIL OF THE SAME SPECIFICATIONS FROM A DIFFERENT LOT WAS USED TO CONTINUE THE PROCEDURE. THE MICROCATHETER, CARRY 2 MARKER, WAS ALSO REPLACED WITH A SL10 TO CONTINUE THE PROCEDURE. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HEALTH DAMAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 922953 | AZUR SOFT3D DETACHABLE 10 | DEVICE, NEUROVASCULAR EMBOLIZATION | KRD | MICROVENTION INC | MV-HS00415 | 0000659071 | 04987892128394 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | STRYKER SL10, UNKNOWN DETAILS| U.T.M CARRY 2 MARKER, UNKNOWN DETAILS |