VERSACROSS CONNECT LAAC ACCESS SOLUTION
Report
- Report Number
- 2124215-2023-15362
- Event Type
- Injury
- Date Received
- April 6, 2023
- Date of Event
- March 16, 2023
- Report Date
- September 1, 2023
- Manufacturer
- BAYLIS MEDICAL COMPANY INC.
- Product Code
- DRE
- UDI-DI
- 00685447012597
- PMA / PMN Number
- K220414
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CORRECTION ON PATIENT CODE : E0605 : CARDIAC TAMPONADE HAS BEEN REMOVED AS THERE WAS NO REPORTED TAMPONADE IN THE EVENT REPORTED TO BOSTON SCIENTIFIC. PREVIOUSLY PROVIDED (IN H10) D2B PRO CODE: DXF, DRE. PREMARKET / 510(K) : K220414, K150709, WERE PROVIDED ON THE VERSACROSS CONNECT KIT, AS IT WAS REPORTED THAT THE RF WIRE WAS NOT INSERTED INTO THE PATIENT. THE PROVIDED PRO CODE AND 510K WERE UPDATED TO THE SHEATH DILATOR COMPONENT OF THE VERSACROSS CONNECT KIT, IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
PRO CODE: DXF, DRE. PREMARKET / 510(K) : K220414,K150709. IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
CORRECTION ON PRODUCT CODE. IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
IT WAS REPORTED THAT DURING TRANSEPTAL PUNCTURE, A MECHANICAL J-TIP WIRE FROM VERSACROSS CONNECT WAS SELECTED FOR USE. THERE WAS A SMALL BASELINE EFFUSION BEHIND THE RIGHT VENTRICLE NOTED PRIOR TO THE PROCEDURE. THE PATIENT WAS HEPARINIZED AND ON ELIQUIS. DURING THE PROCEDURE, THE WIRE WAS PLACED SEVERAL TIMES IN THE SEPTUM TO GET A GOOD POSITIONING, AND WHEN THE WIRE WAS IN THE RIGHT ATRIUM, AND EFFUSION WAS NOTED. IT WAS PRESUMED THAT THIS WIRE PERFORATED THE RIGHT ATRIUM AND CAUSED AN EFFUSION. THIS PROCEDURE WAS CANCELLED., A PERICARDIOCENTESIS WAS PERFORMED, AND A CHEST TUBE WAS REQUIRED. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL. NO DEVICES WERE EVER INSERTED ACROSS THE SEPTUM. THEY WERE NEVER ABLE TO ENGAGE THE SEPTUM AND ATTEMPT A TRANSSEPTAL. THE WATCHMAN FXD SHEATH WITH THE VERSACROSS CONNECT DILATOR WERE THE ONLY SHEATHS/DILATORS USED IN THE PROCEDURE. THE MECHANICAL GUIDEWIRE IN THE VERSACROSS KIT WAS THE ONLY WIRE EVER USED. THE VERSACROSS RF WIRE WAS NEVER INSERTED. THERE WAS NOT ABNORMAL RESISTANCE NOTED, BUT THERE WAS A SIGNIFICANT AMOUNT OF REWIRING DONE IN THE RA, DUE TO THE INABILITY TO FIND A SUITABLE ANGLE TO CROSS THE SEPTUM. THIS DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISPOSED.
IT WAS REPORTED THAT DURING TRANSEPTAL PUNCTURE, A MECHANICAL J-TIP WIRE FROM VERSACROSS CONNECT WAS SELECTED FOR USE. THERE WAS A SMALL BASELINE EFFUSION BEHIND THE RIGHT VENTRICLE NOTED PRIOR TO THE PROCEDURE. THE PATIENT WAS HEPARINIZED AND ON ELIQUIS. DURING THE PROCEDURE, THE WIRE WAS PLACED SEVERAL TIMES IN THE SEPTUM TO GET A GOOD POSITIONING, AND WHEN THE WIRE WAS IN THE RIGHT ATRIUM, AND EFFUSION WAS NOTED. IT WAS PRESUMED THAT THIS WIRE PERFORATED THE RIGHT ATRIUM AND CAUSED AN EFFUSION. THIS PROCEDURE WAS CANCELLED., A PERICARDIOCENTESIS WAS PERFORMED, AND A CHEST TUBE WAS REQUIRED. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL. NO DEVICES WERE EVER INSERTED ACROSS THE SEPTUM. THEY WERE NEVER ABLE TO ENGAGE THE SEPTUM AND ATTEMPT A TRANSSEPTAL. THE WATCHMAN FXD SHEATH WITH THE VERSACROSS CONNECT DILATOR WERE THE ONLY SHEATHS/DILATORS USED IN THE PROCEDURE. THE MECHANICAL GUIDEWIRE IN THE VERSACROSS KIT WAS THE ONLY WIRE EVER USED. THE VERSACROSS RF WIRE WAS NEVER INSERTED. THERE WAS NOT ABNORMAL RESISTANCE NOTED, BUT THERE WAS A SIGNIFICANT AMOUNT OF REWIRING DONE IN THE RA, DUE TO THE INABILITY TO FIND A SUITABLE ANGLE TO CROSS THE SEPTUM. THIS DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISPOSED.
IT WAS REPORTED THAT DURING TRANSEPTAL PUNCTURE, A MECHANICAL J-TIP WIRE FROM VERSACROSS CONNECT WAS SELECTED FOR USE. THERE WAS A SMALL BASELINE EFFUSION BEHIND THE RIGHT VENTRICLE NOTED PRIOR TO THE PROCEDURE. THE PATIENT WAS HEPARINIZED AND ON ELIQUIS. DURING THE PROCEDURE, THE WIRE WAS PLACED SEVERAL TIMES IN THE SEPTUM TO GET A GOOD POSITIONING, AND WHEN THE WIRE WAS IN THE RIGHT ATRIUM, AND EFFUSION WAS NOTED. IT WAS PRESUMED THAT THIS WIRE PERFORATED THE RIGHT ATRIUM AND CAUSED AN EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED, AND A CHEST TUBE WAS REQUIRED. THE PATIENT HAS NOT BEEN DISCHARGED. THIS PROCEDURE WAS CANCELLED. THIS DEVICE WAS DISPOSED. 24 MAR 2023 - GFE RESPONSE: THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL. NO DEVICES WERE EVER INSERTED ACROSS THE SEPTUM. THEY WERE NEVER ABLE TO ENGAGE THE SEPTUM AND ATTEMPT A TRANSSEPTAL. THE WATCHMAN FXD SHEATH WITH THE VERSACROSS CONNECT DILATOR WERE THE ONLY SHEATHS/DILATORS USED IN THE PROCEDURE. THE MECHANICAL GUIDEWIRE IN THE VERSACROSS KIT WAS THE ONLY WIRE EVER USED. THE VERSACROSS RF WIRE WAS NEVER INSERTED. THERE WAS NOT ABNORMAL RESISTANCE NOTED, BUT THERE WAS A SIGNIFICANT AMOUNT OF REWIRING DONE IN THE RA, DUE TO THE INABILITY TO FIND A SUITABLE ANGLE TO CROSS THE SEPTUM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1513984 | VERSACROSS CONNECT LAAC ACCESS SOLUTION | DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION | DRE | BAYLIS MEDICAL COMPANY INC. | VXAK0007 | VMFA270123 | 00685447012597 |
| 2020611 | VERSACROSS CONNECT LAAC ACCESS SOLUTION | DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION | DRE | BAYLIS MEDICAL COMPANY INC. | VXAK0007 | VMFA270123 | 00685447012597 |
| 667169 | VERSACROSS CONNECT LAAC ACCESS SOLUTION | DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION | DRE | BAYLIS MEDICAL COMPANY INC. | VXAK0007 | VMFA270123 | 00685447012597 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Female | Required Intervention| O |