CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM
Report
- Report Number
- 3024985933-2025-00035
- Event Type
- Injury
- Date Received
- September 26, 2025
- Date of Event
- September 4, 2025
- Report Date
- November 26, 2025
- Manufacturer
- ENDOTRONIX, INC
- Product Code
- MOM
- PMA / PMN Number
- P230040
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION WILL BE SUBMITTED VIA FOLLOW-UP REPORT WITHIN 30 DAYS OF RECEIPT.
UPDATED SECTIONS: B4, G3, G6, H2, H3, H6 AND H11. H3: RIGHT HEART CATHETERIZATION IS A PROCEDURE THAT CARRIES INHERENT RISKS, INCLUDING BLEEDING AND VASCULAR COMPLICATIONS. AMONG THESE, CARDIAC TAMPONADE IS A RARE BUT SERIOUS COMPLICATION OF RIGHT HEART CATHETERIZATION CARDIAC TAMPONADE IS A KNOWN PROCEDURAL COMPLICATION AND IS NOTED IN THE PRODUCT'S RISK DOCUMENTS AND INSTRUCTIONS FOR USE (IFU) AS A POTENTIAL RISK OF THE OVERALL PROCEDURE. CARDIAC TAMPONADE IS A RARE BUT SERIOUS ADVERSE EVENT THAT MAY OCCUR SECONDARY TO PATIENT FACTORS AND/OR INJURY TO CARDIAC OR VASCULAR STRUCTURES DURING HANDLING OF INTERVENTIONAL PRODUCTS USED DURING THE IMPLANT PROCEDURE (SUCH AS GUIDEWIRES OR THE DELIVERY SYSTEM). THE IFU WARNS, "EXCESSIVELY FORCEFUL MOVEMENTS OF THE DELIVERY SYSTEM MAY RESULT IN VESSEL INJURY OR PERFORATION. DO NOT ADVANCE DELIVERY SYSTEM IF EXCESSIVE RESISTANCE IS FELT." THE IFU ADDITIONALLY INSTRUCTS THAT "PATIENTS WHO ARE CURRENTLY ON ANTICOAGULANT THERAPY, OR THOSE IN WHICH CHRONIC ANTICOAGULANT THERAPY IS INDICATED FOR HF TREATMENT SHOULD DISCONTINUE USE OF ANTICOAGULANT THERAPY 1-2 DAYS PRIOR TO THE CORDELLA SENSOR IMPLANT AND RESTART TREATMENT POST-IMPLANT. AN INR OF <1.5 IS RECOMMENDED PRIOR TO SENSOR IMPLANT FOR SUBJECTS WHO WERE PREVIOUSLY ON ANTICOAGULANT THERAPY." IN THIS CASE, TAMPONADE WAS NOTED TOWARD THE END OF A TECHNICALLY CHALLENGING IMPLANT PROCEDURE, COMPOUNDED BY ANATOMICAL CHALLENGES, THAT INVOLVED MULTIPLE ATTEMPTS TO ACCESS THE RIGHT PULMONARY ARTERY AND EXCHANGES OF GUIDEWIRES AND DELIVERY SYSTEMS. THE PATIENT'S PRE-EXISTING ANTICOAGULATION THERAPY (ELIQUIS) WAS NOT HELD PRIOR TO THE PROCEDURE, WHICH MAY HAVE INCREASED THE RISK OF BLEEDING AND CONTRIBUTED TO THE SEVERITY OF THE EVENT. DESPITE URGENT PERICARDIOCENTESIS AND SUBSEQUENT INTERVENTIONS, THE PATIENT REQUIRED TRANSFER FOR FURTHER MANAGEMENT, THOUGH ULTIMATELY STABILIZED AND WAS DISCHARGED HOME ON POST-OPERATIVE DAY SEVEN. THE DELIVERY SYSTEM USED DURING THE PROCEDURE WAS DISCARDED AND IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, A PRODUCT MALFUNCTION CANNOT BE CONFIRMED AND A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD (DHR) FOR THE SENSOR LOT WAS REVIEWED, AND IT WAS CONFIRMED THAT ALL MANUFACTURING OPERATIONS AND INSPECTIONS WERE PERFORMED, ALL ACCEPTANCE CRITERIA WERE MET, AND NO RELEVANT NONCONFORMANCES WERE ASSOCIATED WITH THE LOT AT THE TIME OF MANUFACTURE. BASED ON THE AVAILABLE INFORMATION, PROCEDURAL AND/OR PATIENT-SPECIFIC FACTORS, MAY HAVE CONTRIBUTED TO THE EVENT REPORTED. NO ADDITIONAL CORRECTIVE OR PREVENTIVE ACTIONS ARE INDICATED AT THIS TIME. THE CORDELLA SYSTEM CONTINUES TO PROVIDE SIGNIFICANT CLINICAL BENEFIT IN MANAGING CHRONIC HEART FAILURE THROUGH REMOTE PULMONARY ARTERY PRESSURE MONITORING.
ON (B)(6)2025, DURING A COMMERCIAL IMPLANT PROCEDURE AT (B)(6), A PATIENT EXPERIENCED CARDIAC TAMPONADE REQUIRING URGENT PERICARDIOCENTESIS. PRIOR TO THE PROCEDURE THE PATIENT HAD BEEN TAKING ELIQUIS DUE TO A HISTORY OF ATRIAL FIBRILLATION AND STROKE. PER THE PHYSICIAN, THE MEDICATION HAD NOT BEEN HELD IN PREPARATION FOR PROCEDURE. DURING THE PROCEDURE, RIGHT INTERNAL JUGULAR ACCESS WAS GAINED AFTER MULTIPLE NEEDLE STICKS AND THE USE OF ULTRASOUND GUIDANCE. AFTER ACCESS SITE DILATION, THERE WAS DIFFICULTY INSERTING A 14FR SHEATH BUT WAS EVENTUALLY SUCCESSFUL. THE PHYSICIAN ATTRIBUTED THE DIFFICULTY TO THE PATIENT'S ANATOMY WHICH HAD AN ANATOMICAL BEND/TURN. RIGHT PULMONARY ANGIOGRAMS (RPA) WERE COMPLETED, AND A .018 GUIDEWIRE WAS SUCCESSFULLY ADVANCED THROUGH A 7FR SWAN CATHETER INTO THE DISTAL RPA BRANCH. THE SWAN WAS THEN EXCHANGED FOR A DELIVERY SYSTEM; HOWEVER, DURING PLACEMENT, THE WIRE RETRACTED FROM THE RPA, POTENTIALLY DUE TO TENSION IN THE TIP OF THE SYSTEM. ATTEMPTS TO REPOSITION THE GUIDEWIRE INTO THE RPA, WITH THE DELIVERY SYSTEM IN THE MAIN PULMONARY ARTERY, WERE UNSUCCESSFUL AS THE WIRE WOULD ADVANCE INTO THE LEFT PULMONARY ARTERY (LPA). THE DELIVERY WAS THEN ADVANCED DISTALLY INTO THE RPA (TOWARD THE RPA/LPA JUNCTION). ADDITIONAL ATTEMPTS TO THEN PLACE THE WIRE WERE UNSUCCESSFUL. THE GUIDEWIRE WAS REMOVED AND A CURVE ADDED TO THE TIP PRIOR TO REINSERTION INTO THE DELIVERY SYSTEM. AGAIN, THE WIRE WOULD ONLY ADVANCE TOWARD THE LPA AND ATTEMPTS WITH THIS WIRE WERE DISCONTINUED. CONTINUED ATTEMPTS TO ACCESS THE RPA USING VARIOUS WIRES (STEELCORE, J WIRE WITH ADDED TIP CURVE, EXTRA STIFF AMPLATZ) AND BREATH HOLD TECHNIQUE WERE ATTEMPTED BUT UNSUCCESSFUL. AT THIS TIME, IT WAS RECOMMENDED THAT THE DELIVERY SYSTEM AND WIRE BE REMOVED AND A SWAN OR OTHER DIAGNOSTIC CATHETER BE USED TO NAVIGATE TO THE RPA FOLLOWED BY WIRE RE-INSERTION; HOWEVER, THE PHYSICIAN ATTEMPTED TO ADVANCE THE EXISTING DELIVERY SYSTEM AND A .025 EXTRA STIFF AMPLATZ WIRE THROUGH THE PULMONARY VALVE AND INTO THE MAIN PULMONARY SEVERAL TIMES. RPA COULD NOT BE ACCESSED, AND THE DELIVERY SYSTEM AND THE WIRE WERE THEN REMOVED COMPLETELY. NEXT, THE 7FR SWAN WAS REINSERTED AND SUCCESSFULLY ADVANCED TO THE RPA. A .018 STEELCORE WIRE WAS INSERTED INTO THE SWAN AND NAVIGATED SUCCESSFULLY TO AN ACCEPTABLE POSTERIOR DESCENDING BRANCH OF THE RPA. PLACEMENT WAS CONFIRMED WITH IMAGING. A NEW DELIVERY SYSTEM WAS PREPPED AND INSERTED OVER THE STEELCORE WIRE. THE SENSOR WAS CONFIRMED TO BE AT THE TARGET LOCATION VIA IMAGING AND THEN DEPLOYED SUCCESSFULLY. SENSOR CALIBRATION WAS COMPLETED FOLLOWED BY REMOVAL OF ALL CATHETERS AND WIRES AND VENOUS CLOSURE. THE DELIVERY SYSTEM USED DURING THE PROCEDURE WAS DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS. TOWARD THE LATTER HALF OF THE PROCEDURE, THE PATIENT EXPERIENCED SEVERAL EPISODES OF HYPOTENSION. TREATMENT PROVIDED TEMPORARILY INCREASED THE BLOOD PRESSURE. AFTER THE PROCEDURE WAS COMPLETED, WITH THE PATIENT STILL IN THE PROCEDURE ROOM, A CARDIAC ECHOCARDIOGRAM WAS PERFORMED IN LIGHT OF THE HYPOTENSION THAT HAD BEEN OBSERVED. THE PHYSICIAN DETERMINED THAT THE PATIENT WAS EXPERIENCING CARDIAC TAMPONADE. AN INTERVENTIONAL CARDIOLOGIST WAS CALLED TO THE ROOM TO PERFORM URGENT PERICARDIOCENTESIS. 120CC OF FLUID WAS DRAINED BUT THE TAMPONADE DID NOT RESOLVE. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY, AND ANOTHER URGENT CARDIAC ANGIOGRAM WAS COMPLETED TO DETERMINE THE LOCATION CAUSE AND TREATMENT FOR THE TAMPONADE AND DETERMINED; HOWEVER, IF THE LOCATION COULD NOT BE IDENTIFIED, THE PATIENT WOULD BE TAKEN TO THE OPERATING ROOM FOR SURGICAL INTERVENTION. FOLLOW UP INVESTIGATION NOTED THAT ON POST-OPERATIVE DAY (POD) ONE, THE PATIENT WAS REPORTED TO BE STABLE, DESPITE CONTINUED FLUID BUILDUP AROUND THE HEART. ON POD3, THE PATIENT WAS NOTED TO BE IMPROVING BUT MAY STILL HAVE SOME FLUID BUILDUP AROUND THE HEART. MULTIPLE ATTEMPTS TO OBTAIN MEDICAL RECORDS AND ADDITIONAL INFORMATION ON FINAL TREATMENT FOR THE PATIENT HAVE BEEN UNSUCCESSFUL. THE PATIENT WAS DISCHARGED HOME ON POD7 AND WAS ABLE TO SUCCESSFULLY SUBMIT INITIAL READINGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 304243 | CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM | PULMONARY ARTERY SENSOR | MOM | ENDOTRONIX, INC | E240916 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Female | Required Intervention| H |