CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM
Report
- Report Number
- 2029046-2024-01248
- Event Type
- Malfunction
- Date Received
- April 15, 2024
- Date of Event
- March 21, 2024
- Report Date
- April 15, 2024
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- DYB
- UDI-DI
- 10846835016277
- PMA / PMN Number
- K170997
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM AND THERE WAS A NYLON MATERIAL UNRAVELING FROM THE INSIDE OF THE SHEATH. IT WAS REPORTED THAT WHEN REMOVING THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM FROM THE GROIN, POST PROCEDURE, THERE WAS WHAT LOOKED LIKE A NYLON MATERIAL UNRAVELING FROM THE INSIDE OF THE SHEATH. THERE WAS NO RESISTANCE. NO PATIENT CONSEQUENCES NOTES. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. A VISUAL INSPECTION, MICROSCOPIC EXAMINATION, AND FOURIER TRANSFORMED INFRARED SPECTROSCOPY (FT-IR) EVALUATION OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING BWI PROCEDURES. THE CUSTOMER REPORTED THAT A NYLON MATERIAL UNRAVELING WAS OBSERVED WHEN REMOVING THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM FROM THE GROIN; HOWEVER, DURING THE ANALYSIS IN THE LAB A VISUAL INSPECTION REVEALED ANY ANOMALIES OR PHYSICAL DAMAGE ON THE DEVICE. AFTERWARD, THE SHAFT WAS INSPECTED FROM THE INSIDE AND DELAMINATION WAS OBSERVED. DUE TO THIS CONDITION AN FT-IR TEST WAS PERFORMED AND RESULTS REVEALED THAT THE INFRARED SPECTRUM OBTAINED FROM FOREIGN MATERIAL EXHIBITED THE CHARACTERISTIC INFRARED SPECTRUM FOR POLYTETRAFLUOROETHYLENE (PT-FE). A DEVICE HISTORY RECORD WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE FAILURE OBSERVED WITH THE PT-FE COULD BE RELATED TO THE ISSUES REPORTED BY THE CUSTOMER; THEREFORE, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE POTENTIAL CAUSE OF THE PTFE ISSUE COULD BE RELATED TO THE EXCESSIVE FORCE OR MANIPULATION OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING RECOMMENDATIONS: PRIOR TO INSERTING THE DEVICE INTO THE PATIENT, PRE-ASSEMBLE SHEATH, DILATOR AND STYLET ON THE TABLE. ADVANCE THE NEEDLE THROUGH THE DILATOR AND CHECK FOR EXCESSIVE RESISTANCE AS THE TIP OF THE NEEDLE ADVANCES THROUGH THE CURVATURE OF THE SHEATH/DILATOR ASSEMBLY. 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-APR-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).
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. 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 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM AND THERE WAS A NYLON MATERIAL UNRAVELING FROM THE INSIDE OF THE SHEATH. IT WAS REPORTED THAT WHEN REMOVING THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM FROM THE GROIN, POST PROCEDURE, THERE WAS WHAT LOOKED LIKE A NYLON MATERIAL UNRAVELING FROM THE INSIDE OF THE SHEATH. THERE WAS NO RESISTANCE. NO PATIENT CONSEQUENCES NOTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1406696 | CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM | INTRODUCER, CATHETER | DYB | BIOSENSE WEBSTER INC | 00002527 | 10846835016277 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |