PENTARAY NAV
Report
- Report Number
- 2029046-2024-03777
- Event Type
- Malfunction
- Date Received
- November 22, 2024
- Date of Event
- October 30, 2024
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- MTD
- UDI-DI
- 10846835012255
- PMA / PMN Number
- K123837
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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. NOTE: FOR FIELD D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. NOTE: FOR FIELD E1. INITIAL REPORTER PHONE: (B)(6). MANUFACTURER'S REF. # (B)(4).
IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV AND THE SHAFT WAS BROKEN EXPOSING INTERNAL COMPONENTS. IT WAS REPORTED THAT DURING THE OPERATION, THE SHAFT OF THE DEVICE HAD BEEN DAMAGED WHEN THE PACKAGE WAS JUST OPENED. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL INSPECTION REVEALED THAT THE SHAFT AND TIP WERE SEPARATED. EXPOSED WIRES AND EVIDENCE OF POLYURETHANE (PU) WERE OBSERVED IN THE AFFECTED AREA. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE INTERNAL COMPONENT EXPOSED ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE SEPARATION COULD BE RELATED TO THE MANIPULATION OF THE DEVICE BEFORE THE PROCEDURE, HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING RECOMMENDATIONS: DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER THROUGH THE GUIDING SHEATH WHEN RESISTANCE IS ENCOUNTERED. AS PART OF JOHNSON & JOHNSON MEDTECH'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 4-DEC-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 PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV AND THE SHAFT WAS BROKEN EXPOSING INTERNAL COMPONENTS. IT WAS REPORTED THAT DURING THE OPERATION, THE SHAFT OF THE DEVICE HAD BEEN DAMAGED (BROKEN AS THE PHOTO SHOWS) WHEN THE PACKAGE WAS JUST OPENED. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1777984 | PENTARAY NAV | CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY | MTD | BIOSENSE WEBSTER INC | 31389722L | 10846835012255 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |