RIST
Report
- Report Number
- 2029214-2025-00232
- Event Type
- Injury
- Date Received
- January 28, 2025
- Date of Event
- January 24, 2025
- Report Date
- February 24, 2025
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- DQY
- PMA / PMN Number
- K191551
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID 105-5096-000 (B456176); PRODUCT TYPE: IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID 103-0605-200 (B541635); PRODUCT TYPE: MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC RECEIVED INFORMATION REGARDING AN APOLLO CATHETER THAT WAS OCCLUDED DURING USE AND HAD UNIDENTIFIED BLUE MATERIAL COMING OUT OF THE TIP. THE PATIENT WAS UNDERGOING A PROCEDURE FOR ONYX EMBOLIZATION OF A CHRONIC SUBDURAL HEMATOMA. PATIENT VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE APOLLO CATHETER AND ALL ACCESSORY DEVICES WERE PREPARED AND CATHETER FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). INTENTION WAS TO CATHETERIZE THE VESSEL DELIVERING THE APOLLO WITH THE X-PEDION GUIDEWIRE. HOWEVER, DURING THE PROCESS, WHEN REMOVING THE GUIDEWIRE, SOME UNIDENTIFIED BLUE MATERIAL WAS OBSERVED AT THE TIP OF THE MICRO GUIDE, AND THE CATHETER WAS NOTED TO BE OCCLUDED. THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE, BUT THE OCCLUSION PERSISTED, PREVENTING THE PASSAGE OF SERUM. CONSEQUENTLY, THE APOLLO MICRO CATHETER WAS REMOVED. THE PATIENT ENDED UP EXPERIENCING VASOSPASM WHICH PREVENTED CATHETERIZATION OF THE VESSEL SO IT COULD NOT BE EMBOLIZED. THE ACCESS VESSEL WITH A DIAMETER OF 8MM; A RIST 7FR RADIAL ACCESS GUIDE CATHETER WAS USED. THOUGH PATIENT VASOSPASM WAS REPORTED, IT WAS NOTED THAT PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE ISSUE WITH THE APOLLO CATHETER, AND NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT PERMANENT IMPAIRM ENT.
ADDITIONAL INFORMATION RECEIVED REPORTED CATHETER OCCLUSION AND UNIDENTIFIED MATERIAL WAS OBSERVED DURING USE. A NEW XPEDIO MICRO TAB WAS OPENED FOR THIS ACCESS, WHICH HAD NOT BEEN USED BEFORE. THE RIST CATHETER WAS POSITIONED FROM THE BEGINNING OF THE PROCEDURE, THE VESSEL SPASM WAS IN THE PEDICLE OF THE BRANCH TO BE EMBOLIZED, WHERE THE CATHETER DOES NOT REACH. THE PATIENT'S VASOSPASM WAS CAUSED BY ATTEMPTED CATHETERIZATION OF X-PEDION AND APOLLO. THE DOCTOR PREFERRED NOT TO INTERVENE AND LEAVE IT WITHOUT ANY INTERVENTION, AND REVERSE IT SPONTANEOUSLY. DMSO WAS FILLED IN THE APOLLO DEAD SPACE. ONYX WAS CONNECTED AND AN ATTEMPT WAS MADE TO EMBOLIZE IT. IT WAS THEN REALIZED THAT THE INJECTION WAS NOT PROGRESSING, THE DMSO WAS FLOWING, BUT THE ONYX WAS NOT. THERE WAS NO LEFTOVER ONYX OR DMSO TO RETURN. THERE WAS NO ABNORMALITIES SUCH AS FRICTION OR DIFFICULTY DURING FLUSHING OR INJECTION OF THE APOLLO CATHETER. THERE WAS NO DAMAGE OBSERVED TO THE X-PEDION GUIDEWIRE.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PROCEDURE WAS CANCELLED DUE TO THE TIME IN THE ROOM, ANESTHESIA, AND AFTER THE CATHETER WAS REMOVED, THE VESSEL SPASMED MORE THAN BEFORE, WHICH DID NOT ALLOW ANY FURTHER CATHETERIZATION OF THAT BRANCH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1548764 | RIST | CATHETER, PERCUTANEOUS | DQY | MICRO THERAPEUTICS, INC. DBA EV3 | 107F-079-95 | 25410-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |