FLEXCATH CROSS TRANSSEPTAL SOLUTION
Report
- Report Number
- 3012120746-2025-00038
- Event Type
- Malfunction
- Date Received
- November 13, 2025
- Date of Event
- October 17, 2025
- Report Date
- January 21, 2026
- Manufacturer
- ACUTUS MEDICAL INC
- Product Code
- DYB
- UDI-DI
- 00763000935504
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT EVENT SUMMARY: THE INTEGRATED DILATOR/NEEDLE SYSTEM 900310 OF LOT NUMBER 106646 WAS RETURNED AND ANALYZED. VISUAL INSPECTION WAS CARRIED OUT. NO ANOMALIES WERE OBSERVED WITH THE RETURNED INTEGRATED DILATOR/NEEDLE SYSTEM. THE USABLE LENGTH, CURVE ANGLE AND PLANARITY VERIFICATION WAS PERFORMED AND NO ANOMALIES WERE OBSERVED. THE RETURNED INTEGRATED DILATOR/NEEDLE SYSTEM WAS FLUSHED SMOOTHLY AND NO AIR INGRESS WAS OBSERVED DURING ASPIRATION. IN CONCLUSION, THE REPORTED AIR INGRESS WAS NOT REPRODUCED THE INTEGRATED DILATOR/NEEDLE SYSTEM PASSED THE RETURN PRODUCT INSPECTION. 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 10FCC13 (UNKNOWN SERIAL/LOT); PRODUCT TYPE: 0629-FLEXCATH SHEATH. 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.
IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, THE INTEGRATED DILATOR/NEEDLE SYSTEM WAS INSERTED IN THE SHEATH AND RAISED UP TO THE SUPERIOR VENA CAVA (SVC). A SYRINGE WAS ATTACHED TO THE LUER AND AIR WAS INTERMITTENTLY DRAWN DURING ASPIRATION. THE INTEGRATED DILATOR/NEEDLE SYSTEM WAS REPLACED. THE CASE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS LATER REPORTED THAT AIR BEING DRAWN FROM THE INTEGRATED DILATOR/NEEDLE ONLY. THE INTEGRATED DILATOR/NEEDLE WAS REPLACED WHICH RESOLVED THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 254886 | FLEXCATH CROSS TRANSSEPTAL SOLUTION | INTRODUCER, CATHETER | DYB | ACUTUS MEDICAL INC | 900310 | 106646 | 00763000935504 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |