PENTARAY NAV
Report
- Report Number
- 2029046-2025-01634
- Event Type
- Malfunction
- Date Received
- May 20, 2025
- Date of Event
- April 30, 2025
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- MTD
- UDI-DI
- 10846835012255
- PMA / PMN Number
- K123837
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REF. # (B)(4).
ON 20-MAY-2025, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING ALL THE PIECES WERE REMOVED FROM THE BODY. ADDITIONALLY, A PICTURE OF THE DEVICE WAS PROVIDED BY THE CUSTOMER; THE PRODUCT HAS NOT RETURNED FOR ANALYSIS. EVALUATION OF THE PICTURE IS STILL IN PROGRESS AND IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).
ON 19-NOV-2025, ADDITIONAL INFORMATION WAS RECEIVED FROM A LITERATURE SOURCE. THIS INFORMATION IS FROM A LITERATURE SOURCE HEART RHYTHM CASE REPORTS, VOL 11, NO 11, NOVEMBER 2025. THE FOLLOWING LITERATURE CITE WAS RECEIVED: FIRST REPORTED CASE OF MULTIELECTRODE MAPPING CATHETER DELAMINATION DETECTED BY INTRACARDIAC ECHOCARDIOGRAPHY DURING ATRIAL FIBRILLATION ABLATION MARIA CHIARA GATTO, MD, PHD, LETIZIA VERTICELLI, CPT, GIUSEPPE LUMIA, MD, CESARE BELLINI, MD, ACHILLE GASPARDONE, MD, PHD, FILIPPO LAMBERTI, MD, PHD. FROM THE UNIT OF CARDIOLOGY, EMERGENCY DEPARTMENT, SANT¿EUGENIO HOSPITAL, ROME, ITALY INTRODUCTION ELECTROANATOMIC MAPPING WITH MULTIPOLAR CATHETERS IS COMMON PRACTICE DURING ATRIAL FIBRILLATION (AF) ABLATION. ALTHOUGH THESE CATHETERS ARE GENERALLY SAFE, RARE COMPLICATIONS RELATED TO CATHETER INTEGRITY HAVE BEEN DESCRIBED. THE USE OF MULTIPOLAR MAPPING CATHETERS MAY STILL BE ASSOCIATED WITH SPECIFIC RISKS, INCLUDING THROMBUS FORMATION, ENTRAPMENT OR INJURY OF VALVULAR STRUCTURES, AND POTENTIAL MECHANICAL FAILURE BECAUSE OF THEIR COMPLEX DESIGN WITH MULTIPLE SPLINES AND ELECTRODES. OBJECTIVE: WE REPORT A CASE IN WHICH INTRACARDIAC ECHOCARDIOGRAPHY (ICE) ENABLED EARLY DETECTION OF A FILAMENTOUS FOREIGN BODY EMERGING FROM A PENTARAY (BIOSENSE WEBSTER) MAPPING CATHETER, LIKELY BECAUSE OF PARTIAL DELAMINATION OF THE SPLINE COVERING. CONCLUSIONS: DEVICE-RELATED DELAMINATION OF THE MAPPING CATHETER IS A RARE BUT POTENTIALLY DANGEROUS EVENT. PROMPT RECOGNITION THROUGH ICE CAN PREVENT SERIOUS COMPLICATIONS. THIS CASE HIGHLIGHTS THE IMPORTANCE OF EARLY DETECTION, VIGILANCE, AND REPORTING OF DEFECTIVE EQUIPMENT TO IMPROVE PROCEDURAL SAFETY OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: CARTO 3 (BIOSENSE WEBSTER, INC., IRVINE, CA), CARTOSOUND (BIOSENSE WEBSTER, INC., IRVINE, CA), ICE GUIDANCE. TWO RIGHT FEMORAL AND 2 LEFT FEMORAL VENOUS ACCESSES WERE OBTAINED, AND TRANSSEPTAL PUNCTURE WAS PERFORMED USING A RADIOFREQUENCY NEEDLE (NRG TRANSSEPTAL NEEDLE, BAYLIS MEDICAL) UNDER ICE GUIDANCE WITH A SINGLE PUNCTURE. 1 CASE OF DETECTION OF A FILAMENTOUS FOREIGN BODY EMERGING FROM A PENTARAY (BIOSENSE WEBSTER) MAPPING CATHETER, LIKELY BECAUSE OF PARTIAL DELAMINATION OF THE SPLINE COVERING. CASE REPORT INDICATED THAT THE PATIENT WAS ELECTIVELY REFERRED TO OUR ELECTROPHYSIOLOGY LABORATORY FOR PULMONARY VEIN ISOLATION USING A WIDE AREA CIRCUMFERENTIAL ABLATION STRATEGY. THE PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA. TWO RIGHT FEMORAL AND 2 LEFT FEMORAL VENOUS ACCESSES WERE OBTAINED, AND TRANSSEPTAL PUNCTURE WAS PERFORMED USING A RADIOFREQUENCY NEEDLE (NRG TRANSSEPTAL NEEDLE, BAYLIS MEDICAL) UNDER ICE GUIDANCE WITH A SINGLE PUNCTURE. NO DIFFICULTIES OR COMPLICATIONS WERE ENCOUNTERED DURING VASCULAR ACCESS, SHEATH INSERTION, OR TRANSSEPTAL PUNCTURE. THE PROCEDURE WAS PERFORMED USING THE CARTO 3 (BIOSENSE WEBSTER, INC., IRVINE, CA) ELECTROANATOMIC MAPPING SYSTEM WITH THE CARTOSOUND (BIOSENSE WEBSTER, INC., IRVINE, CA) MODULE AND ICE GUIDANCE, WITHOUT THE USE OF FLUOROSCOPY. NO RESISTANCE OR DIFFICULTIES WERE ENCOUNTERED DURING THE ADVANCEMENT OF THE MAPPING CATHETER THROUGH THE SHEATH AND ITS HEMOSTATIC VALVE. IMMEDIATELY AFTER ADVANCING THE MAPPING CATHETER INTO THE LEFT ATRIUM THROUGH A LONG SHEATH, ICE REVEALED A FILAMENTOUS, HYPERECHOGENIC, MOBILE STRUCTURE EXTENDING FROM ONE OF THE CATHETER¿S SPLINES (FIGURE 1 AND SUPPLEMENTAL VIDEO 1). THE STRUCTURE APPEARED TO FLOAT FREELY IN THE BLOOD POOL, WITHOUT ATTACHMENT TO ENDOCARDIAL SURFACES, RAISING SUSPICION FOR FOREIGN MATERIAL. THE CATHETER WAS PROMPTLY WITHDRAWN. UPON EXTERNAL INSPECTION, A LONG PLASTIC FILAMENT, SEVERAL CENTIMETERS IN LENGTH, WAS FOUND PROTRUDING FROM ONE OF THE ELECTRODES ON A SPLINE (FIGURE 2A AND 2C). THE FILAMENT BRANCHED INTO 2 DISTAL SEGMENTS, SUGGESTING A STRUCTURAL DELAMINATION OR DEFECT OF THE CATHETER¿S INSULATING MATERIAL (FIGURE 2B AND SUPPLEMENTAL VIDEO 2). BEFORE PROCEEDING WITH THE INSERTION OF A NEW MAPPING CATHETER, THE TRANSSEPTAL SHEATH AND ITS HEMOSTATIC VALVE WERE CAREFULLY INSPECTED ALONG THEIR ENTIRE LENGTH TO RULE OUT ANY MECHANICAL DEFECTS, IRREGULARITIES, OR SIGNS OF DAMAGE. NO ABNORMALITIES WERE DETECTED, AND ICE CONFIRMED THE ABSENCE OF ANY RESIDUAL INTRALUMINAL MATERIAL OR COMPLICATIONS. ON THE BASIS OF THESE FINDINGS, WE FELT CONFIDENT USING THE SAME SHEATH TO COMPLETE THE PROCEDURE WITH AN OCTARAY (BIOSENSE WEBSTER) CATHETER. THE PATIENT REMAINED HEMODYNAMICALLY STABLE, AND NO COMPLICATIONS WERE OBSERVED DURING OR AFTER THE PROCEDURE. THE DEFECTIVE CATHETER WAS RETAINED FOR DOCUMENTATION AND REPORTED TO THE MANUFACTURER FOR FURTHER ANALYSIS. THE PATIENT WAS MONITORED FOR 48 HOURS AFTER THE PROCEDURE, DURING WHICH NO COMPLICATIONS WERE OBSERVED. AT 30-DAY FOLLOW UP, THE PATIENT REMAINED FREE FROM AF RECURRENCES AND HAD NOT EXPERIENCED ANY MAJOR ADVERSE CARDIAC EVENTS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV AND ONE OF THE SPLINES FRAYED. BEFORE INSERTING THE PENTARAY NAV, IT WAS INTACT. WE NOTICED THE BREAKAGE THROUGH INTRACARDIAC ECHO (ICE). THE PENTARAY NAV WAS THEN IMMEDIATELY REMOVED AND WE NOTICED THAT A METAL WIRE WAS COMING OUT OF ONE OF THE SPLINES. THE CATHETER WAS IMMEDIATELY REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. DEVICE INVESTIGATION DETAILS: A PICTURE WAS RECEIVED FOR EVALUATION FOLLOWING JOHNSON & JOHNSON MEDTECH'S PROCEDURES. ACCORDING TO PICTURES PROVIDED BY THE CUSTOMER, A FIBER LIKE MATERIAL WAS OBSERVED ENTANGLED IN THE SPLINES OF THE PENTARAY. HOWEVER, NO PHYSICAL DAMAGE WAS OBSERVED ON THE CATHETER. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO INTERNAL ACTION RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE PICTURE RECEIVED. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AND A ROOT CAUSE IS UNABLE TO BE ASSIGNED BASED ON THE CURRENT EVIDENCE. IF THE DEVICE IS RECEIVED IN THE FUTURE, THE PRODUCT INVESTIGATION WILL BE PERFORMED AND UPDATED ACCORDINGLY, AND ANY ACTION WILL BE TAKEN IF NECESSARY. NOTE: H6. INVESTIGATION FINDINGS CODE OF ¿APPROPRIATE TERM/CODE NOT AVAILABLE (C22)¿ USED TO REPRESENT THE PHOTO ANALYSIS RESULTS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).
ON 28-MAY-2025, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE OPERATOR CLAIMED TO HAVE FELT SOME RESISTANCE DURING THE INSERTION OF PENTARAY NAV INTO THE SHEATH. THE SHEATH WAS NOT DAMAGED. ONE OF THE PROXIMAL ELECTRODES OF A SPLINE APPEARED TO BE VISUALLY DAMAGED. THE SHEATH WAS THE TORFLEX TRANSSEPTAL GUIDING SHEATH 8.5F (FOUND IN THE NRG RF TRANSSEPTAL KIT, BAYLIS MEDICAL). THEY WOULD LIKE TO POINT OUT THAT WHEN THE CATHETER WAS REPLACED, THE NEW CATHETER WAS INSERTED INTO THE SAME SHEATH WITHOUT ANY PROBLEMS. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J) FOR EVALUATION ON 9-JUN-2025. A VISUAL INSPECTION EVALUATION OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL INSPECTION OF THE RETURNED SAMPLE REVEALED A LIFTED ELECTRODE IN ONE OF THE SPLINES, NO OTHER ANOMALIES WERE DETECTED. EVIDENCE OF CORRECTLY ASSEMBLY WAS OBSERVED. ACCORDING TO THE PICTURE PROVIDED BY THE CUSTOMER, A METAL WIRE FIBER WAS OBSERVED ATTACHED TO THE SPLINES; HOWEVER, DURING THE INSPECTION NO FOREIGN MATERIAL WAS FOUND. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. SINCE AN ELECTRODE DAMAGE WAS OBSERVED, THIS FAILURE COULD BE RELATED TO THE METAL WIRE BEING ATTACHED TO THE SPLINES; THEREFORE, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE POTENTIAL CAUSE OF THIS DAMAGE COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. AS PART OF THE JOHNSON & JOHNSON MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV AND ONE OF THE SPLINES FRAYED. BEFORE INSERTING THE PENTARAY NAV, IT WAS INTACT. WE NOTICED THE BREAKAGE THROUGH INTRACARDIAC ECHO (ICE). THE PENTARAY NAV WAS THEN IMMEDIATELY REMOVED AND WE NOTICED THAT A METAL WIRE WAS COMING OUT OF ONE OF THE SPLINES. THE CATHETER WAS IMMEDIATELY REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2143333 | PENTARAY NAV | CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY | MTD | BIOSENSE WEBSTER INC | 31538498L | 10846835012255 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Male | TORFLEX TRANSSEPTAL GUIDING SHEATH 8.5F |