VIZIGO
Report
- Report Number
- 2029046-2024-02395
- Event Type
- Malfunction
- Date Received
- July 17, 2024
- Date of Event
- June 21, 2024
- Report Date
- August 20, 2024
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- DYB
- UDI-DI
- 10846835016253
- PMA / PMN Number
- K170997
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ON 26-JUL-2024, NOTED A CORRECTION TO THE 3500A INITIAL AS THE G1. MANUFACTURING SITE NAME WAS PROCESSED UNDER BIOSENSE WEBSTER INC (IRVINE) AND SHOULD HAVE BEEN PROCESSED AS FREUDENBERG MEDICAL LLC. CORRECTED G1. MANUFACTURING SITE NAME. IN ADDITION, CORRECTED G1. MANUFACTURER SITE ADDR. STREET LINE 1, G1. MANUFACTURER SITE CITY, G1. MANUFACTURER SITE STATE CODE AND G1. MANUFACTURER SITE ZIP CODE AND G1. MANUFACTURER SITE COUNTRY CODE. THE DEVICE EVALUATION DETAILS: IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A VIZIGO SHEATH. REPORTED OCCLUSION / NO IRRIGATION. DURING THE PROCEDURE, THE DEVICE (INCLUDING PORT, LUER HUB) WAS NOT IRRIGATING. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS AN ALERT FROM THE IRRIGATION PUMP. THE PHYSICIAN DID NOT FEEL RESISTANCE BETWEEN THE CATHETER AND THE SHEATH. THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. VISUAL INSPECTION, IRRIGATION TEST AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED THAT THE HEMOSTATIC VALVE WAS BROKEN IN THE STAR SECTION. A MICROSCOPIC EXAMINATION OF THE HEMOSTATIC VALVE SURFACE SHOWED STRESS MARKS ON THE DAMAGE. THE BROKEN CONDITION COULD BE RELATED TO THE INCORRECT INSERTION OF THE DILATOR INTO THE SHEATH; THE STRESS MARKS AND PHYSICAL DAMAGE OBSERVED SUGGEST THAT EXCESSIVE FORCE OR MANIPULATION WAS APPLIED; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE IRRIGATION TEST WAS PERFORMED AND NO IRRIGATION ISSUES WERE OBSERVED. A DEVICE HISTORY RECORD 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 POTENTIAL CAUSE OF THE BROKEN HEMOSTATIC VALVE COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATIONS: USE BEST PRACTICES FOR INSERTING OR RETRACTING ANY DEVICE AT THE HEMOSTATIC VALVE; DO NOT REMOVE DILATOR OR CATHETER RAPIDLY. DAMAGE TO HEMOSTATIC VALVE MAY OCCUR. AS PART OF THE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. EXPLANATION OF CODES: -INVESTIGATION FINDINGS: NO DEVICE PROBLEM FOUND (C19)/ INVESTIGATION CONCLUSIONS: NO PROBLEM DETECTED (D14) WERE SELECTED AS RELATED TO THE CUSTOMER¿S REPORTED ¿IRRIGATION¿ ISSUE. -INVESTIGATION FINDINGS: FRACTURE PROBLEM (C070603) / INVESTIGATION CONCLUSIONS: UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT (D1102) / COMPONENT CODE: VALVE(S) (G04135) WERE SELECTED AS RELATED TO THE IOSENSE WEBSTER INC. ANALYSIS FINDING OF THE ¿HEMOSTATIC VALVE WAS BROKEN IN THE STAR SECTION¿. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
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 REFERENCE NUMBER: (B)(4).
THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 19-JUL-2024. THE 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 REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A VIZIGO SHEATH AND AN IRRIGATION ISSUE OCCURRED DURING USE ON THE PATIENT. REPORTED OCCLUSION / NO IRRIGATION. DURING THE PROCEDURE, THE DEVICE (INCLUDING PORT, LUER HUB) WAS NOT IRRIGATING. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 07-JUL-2024. THERE WAS AN ALERT FROM THE IRRIGATION PUMP. THE PHYSICIAN DID NOT FEEL RESISTANCE BETWEEN THE CATHETER AND THE SHEATH. THE ISSUE WAS RESOLVED BY REPLACING WITH A NEW SHEATH. THE IRRIGATION ISSUE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE THAT THE IRRIGATION ISSUE OCCURRED DURING USE ON THE PATIENT ON (B)(6) 2024 AND HAVE REASSESSED THE EVENT AS REPORTABLE. THE AWARENESS DATE FOR THIS RECORD IS 07-JUL-2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 366399 | VIZIGO | INTRODUCER, CATHETER | DYB | BIOSENSE WEBSTER INC | 00002440 | 10846835016253 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | MERIT NEEDLE FND-019-05.| UNK IRRIGATION PUMP.| UNK SMARTTOUCH CATHETER. |