ADVISOR¿ HD GRID X¿ MAPPING CATHETER, SENSOR ENABLED¿
Report
- Report Number
- 3005334138-2025-00506
- Event Type
- Injury
- Date Received
- August 21, 2025
- Date of Event
- July 31, 2025
- Report Date
- October 24, 2025
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- MTD
- UDI-DI
- 05415067049889
- PMA / PMN Number
- K241372
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: B5, G3, H2, H6. ONE BI-DIRECTIONAL, CURVE D-F, SENSOR ENABLED, ADVISOR HD GRID X MAPPING CATHETER WAS RECEIVED FOR EVALUATION. ONE IMAGE WAS ALSO SUBMITTED TO PRODUCT PERFORMANCE ENGINEERING FOR EVALUATION. NO THROMBUS WAS NOTED ON THE RETURNED DEVICE; HOWEVER, THE IMAGE SUBMITTED WITH THE RETURNED DEVICE SHOWS A THROMBUS ON THE PADDLE ASSEMBLY. NO RESISTANCE OR FUNCTIONAL ANOMALIES WERE NOTED WHEN THE CATHETER WAS ADVANCED THROUGH A SHEATH ASSEMBLY FROM CURRENT INVENTORY. IN ADDITION, THE CATHETER MET ACCEPTABLE IRRIGATION RATES DURING A FLOW TEST WITH NO ANOMALIES NOTED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE CAUSE OF THE THROMBUS AND REPORTED WITHDRAWAL DIFFICULTY REMAINS UNKNOWN.
ADDITIONAL INFORMATION: D9, G3, H2, H3, H6. ONE BI-DIRECTIONAL, CURVE D-F, SENSOR ENABLED, ADVISOR HD GRID X MAPPING CATHETER WAS RECEIVED FOR EVALUATION. ONE IMAGE WAS ALSO SUBMITTED TO PRODUCT PERFORMANCE ENGINEERING FOR EVALUATION. NO THROMBUS WAS NOTED ON THE RETURNED DEVICE; HOWEVER, THE IMAGE SUBMITTED WITH THE RETURNED DEVICE SHOWS A THROMBUS ON THE PADDLE ASSEMBLY. NO RESISTANCE OR FUNCTIONAL ANOMALIES WERE NOTED WHEN THE CATHETER WAS ADVANCED THROUGH A SHEATH ASSEMBLY FROM CURRENT INVENTORY. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE CAUSE OF THE THROMBUS AND REPORTED WITHDRAWAL DIFFICULTY REMAINS UNKNOWN.
DURING ATRIAL FIBRILLATION PROCEDURE, THERE WAS A THROMBUS NOTED AT THE END OF THE ADVISOR HD GRID X. ULTRASOUND IMAGING WAS PERFORMED PRIOR TO PROCEDURE TO RULE OUT ANY THROMBUS. AFTER BROCKENBROUGH, LEFT ATRIAL MAPPING (PREMAP) WAS PERFORMED USING THE SHEATH (ABROAD) AND HD GRID X FROM THE RIGHT INGUINAL PUNCTURE SITE. DURING THE INITIAL PULMONARY VEIN ISOLATION USING PFA, THE REPORTED CATHETER WAS REMOVED FROM THE BODY, AND NO THROMBUS WAS OBSERVED AT THAT TIME.AFTER THE PULMONARY VEIN WAS ISOLATED USING PFA (FARA PULSE), LEFT ATRIUM MAPPING (POSTMAP) WAS PERFORMED USING HD GRID X. AS THE RESIDUAL POTENTIAL WAS CONFIRMED IN THE RIGHT CARINA, AN ADDITIONAL APPLICATION USING FARA WAVE WAS PERFORMED. AT THE TIME OF ADDITIONAL PFA, THE HDG WAS PLACED IN THE RIGHT ATRIUM. MAPPING WAS NOT PERFORMED AFTER THE ADDITIONAL PFA, AND THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE CATHETER AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. WHEN THE PHYSICIAN REMOVED THE HDGRIDX FROM THE PATIENT¿S BODY, IT WAS FOUND THAT A 2×1 MM THROMBUS WAS ON THE TIP OF THE A-1 PADDLE PART. IN ADDITION, THE PHYSICIAN STATED THAT THERE WAS STRONG RESISTANCE TO REMOVAL OF HDGRID X FROM THE SHEATH. SINCE TWO SHEATH HAD BEEN USED, THE HD GRID WAS INSERTED INTO EACH SHEATH TO CHECK PUSH-PULL RESISTANCE AFTER THE PROCEDURE, AND RESISTANCE WAS FOUND IN ONLY ONE OF THE SHEATHS, SO THE SHEATH WAS SUSPECTED AS THE CAUSE. THE HD GRID HAD BEEN IRRIGATED WITH HEPARINIZED SALINE USING A PRESSURE BAG.
THIS REPORT INCLUDES AN UPDATED ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 466577 | ADVISOR¿ HD GRID X¿ MAPPING CATHETER, SENSOR ENABLED¿ | CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY | MTD | ABBOTT MEDICAL | D-AVHDX-DF16 | 10847779 | 05415067049889 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |