CATHERA
Report
- Report Number
- 2029214-2024-01254
- Event Type
- Injury
- Date Received
- July 17, 2024
- Date of Event
- June 5, 2024
- Report Date
- September 12, 2024
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- KRA
- PMA / PMN Number
- K151638
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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. 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.
CONTINUATION OF D10: PRODUCT ID: ISF-055-030 (LOT: B648091); IMPLANT DATE: N/A; EXPLANT DATE: N/A. PRODUCT ID: ISF-050-040 (LOT: B451211); IMPLANT DATE: N/A; EXPLANT DATE: N/A. PRODUCT ID: (18550-01). A2. ONLY THE PATIENT'S YEAR OF BIRTH WAS REPORTED BY THE SITE. THEREFORE, ONLY THE YEAR (1951) OF THE REPORTED BIRTHDATE IS VALID. 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.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT PER SOURCE REVIEW, AMELIORATION OF PARESTHESIA IN THE RIGHT HAND WAS REPORTED; THE SITE WAS QUERIED TO ASSESS RELATIONSHIP TO THE PROCEDURE A RIST DEVICE WHICH WAS USED FOR RIGHT RADIAL ACCESS.
ADDITIONAL INFORMATION RECEIVED REPORTED CLARIFICATION OF THE OF THE ADVERSE EVENT TERM NOTING THE EVENT WAS A CUTANEOUS RASH. IT WAS NOTED THE AMELIORATION OF THE PARESTHESIA IN THE PATIENT'S RIGHT HAND/ULNAR TERRITORY WAS ASSOCIATED WITH THE TRANSRADIAL BAND AND WAS NOT A SEPARATE ADVERSE EVENT.
MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO HAD UNDERGONE A PROCEDURE TO TREAT A MIDLINE ANTERIOR COMMUNICATING (ACOM) ARTERY BIFURCATION SACCULAR ANEURYSM ON (B)(6) 2024. THE ANEURYSM MAX DIAMETER WAS 3.5MM AND THE ANEURYSM NECK WAS 3.8MM. AT LEAST 2 ARTISSE DEVICES WERE USED IN THE PROCEDURE AS WELL AS A RIST RADIAL ACCESS CATHETER AND A PHENOM PLUS GUIDE CATHETER. IT WAS REPORTED THAT THE DAY AFTER THE PROCEDURE, ON (B)(6) 2024, THE PATIENT EXPERIENCED "CUTANEOUS RUSH" AS EVIDENCED BY AN ERYTHEMATOUS, MACULOPAPULAR, NON-MIGRATORY, PRURITIC AND PAINFUL PLAQUE ON THE SKIN OF THE PATIENT'S LEFT FLANK, WITHOUT DESQUAMATION. THE OBSERVATION WAS SUGGESTIVE OF A RECURRENCE OF SHINGLES AND THE PATIENT WAS TREATED WITH VALACYCLOVIR. THE EVENT WAS NOT LIFE-THREATENING AND DID NOT RESULT IN PATIENT DISABILITY. HOWEVER, THE PATIENT'S HOSPITALIZATION WAS PROLONGED. SITE ASSESSMENT OF THE EVENT CONCLUDED IT WAS POSSIBLY RELATED TO THE PROCEDURE BUT NOT TO THE DEVICES UTILIZED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2040397 | CATHERA | CATHETER, CONTINUOUS FLUSH | KRA | MICRO THERAPEUTICS, INC. DBA EV3 | UNK-NV-FG19 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Female | Other| H | SEE H11... |