PENTARAY NAV
Report
- Report Number
- 2029046-2024-02490
- Event Type
- Malfunction
- Date Received
- July 24, 2024
- Date of Event
- July 1, 2024
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- MTD
- UDI-DI
- 10846835012255
- PMA / PMN Number
- K123837
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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).
IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PENTARAY NAV AND IRRIGATION COULD NOT BE CONDUCTED. ABOUT 2 HOURS AFTER THE PENTARAY NAV CATHETER WAS USED, DURING REMOVAL OF THE PENTARAY NAV CATHETER FOR REPLACEMENT WITH THE LASSO CATHETER, IT WAS FOUND THAT THE PENTARAY NAV CATHETER COULD NOT DRIP. THE ISSUE WAS IMPROVED BY REPLACING THE CATHETER TO ANOTHER NEW ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. VISUAL INSPECTION AND IRRIGATION TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. AN IRRIGATION TEST WAS PERFORMED, AND THE DEVICE WAS IRRIGATED CORRECTLY. NO IRRIGATION ISSUES WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE IRRIGATION ISSUE REPORTED BY THE CUSTOMER COULD NOT BE REPLICATED DURING THE PRODUCT INVESTIGATION; OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING RECOMMENDATIONS: FLUSH THE CATHETER WITH HEPARINIZED SALINE PRIOR TO INSERTION INTO THE BODY. AS PART OF BIOSENSE WEBSTER¿S 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).
ON 29-JUL-2024, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. THE PRODUCT ANALYSIS HAS BEGUN BUT 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).
IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PENTARAY NAV AND IRRIGATION COULD NOT BE CONDUCTED. ABOUT 2 HOURS AFTER THE PENTARAY NAV CATHETER WAS USED, DURING REMOVAL OF THE PENTARAY NAV CATHETER FOR REPLACEMENT WITH THE LASSO CATHETER, IT WAS FOUND THAT THE PENTARAY NAV CATHETER COULD NOT DRIP. THE ISSUE WAS IMPROVED BY REPLACING THE CATHETER TO ANOTHER NEW ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE IRRIGATION ISSUE WAS SUSPECTED TO BE WITH THE CATHETER AS NO PUMP WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2370779 | PENTARAY NAV | CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY | MTD | BIOSENSE WEBSTER INC | 31113709L | 10846835012255 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | UNK_LASSO. |