VERSACROSS CONNECT LAAC ACCESS SOLUTION
Report
- Report Number
- 2124215-2023-09857
- Event Type
- Injury
- Date Received
- April 25, 2023
- Date of Event
- February 9, 2023
- Report Date
- May 23, 2023
- Manufacturer
- BAYLIS MEDICAL COMPANY INC.
- Product Code
- DXF
- UDI-DI
- 00685447012573
- PMA / PMN Number
- K150709
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CORRECTIONS: B1 ADVERSE EVENT/PRODUCT PROBLEM UPDATED FROM ADVERSE EVENT/PRODUCT PROBLEM TO ADVERSE EVENT F10/H6 DEVICE CODES, CHANGED FROM A150204 FAILURE TO ADVANCE TO A24 ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM. 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.
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.
IT WAS REPORTED THAT DURING A WATCHMAN LAA PROCEDURE A VERSACROSS CONNECT RF WIRE WAS SELECTED FOR USE. DURING POSITIONING, TENTING WAS PERCEIVED IN AN APPROPRIATE LOCATION ON THE FOSSA OVALE. DURING THE RF TRANSEPTAL PUNCTURE, IT WAS BELIEVED THAT THE DEVICE PUNCTURED THROUGH THE POSTERIOR WALL OF THE RIGHT ATRIUM. ECHO IMAGING WAS INDICATIVE OF AN APPROPRIATE TRAJECTORY AFTER RADIOFREQUENCY ENERGY WAS APPLIED, BUT THERE WAS NO ACCESS TO THE LEFT ATRIUM; IT WAS EVIDENT THAT THE SEPTUM WAS NOT CROSSED. A PERICARDIAL EFFUSION (PE) WAS THEN NOTED IN THE RIGHT ATRIUM. PERICARDIAL EFFUSION RESULTED IN >250CC OF BLOOD LOSS, AND A SIGNIFICANT DROP IN BLOOD PRESSURE AND HEART RATE. THE EFFUSION WAS ROUGHLY 0.59 CM, AFTER THE PROCEDURE, THE EFFUSION WAS NOTICEABLY LARGER. THEREFORE, THE PERICARDIOCENTESIS KIT WAS USED TO DRAIN THE EFFUSION. THE PATIENT COULD NOT BE STABILIZED, SO THEY WERE TRANSPORTED TO THE OPERATING ROOM (OR) FOR CT SURGERY AND BLOOD TRANSFUSION. THE PATIENT RECOVERED AND IS DOING WELL. SINCE THE INITIAL GROIN ACCESS, FORTY MINUTES PASSED UNTIL THE ISSUE WAS ENCOUNTERED. THIS PROCEDURE WAS CANCELLED. THE DEVICE WILL NOT BE RETURNED SINCE IT WAS DISCARDED AT THE FACILITY.
IT WAS REPORTED THAT DURING A WATCHMAN LAA PROCEDURE A VERSACROSS CONNECT RF WIRE WAS SELECTED FOR USE. DURING POSITIONING, TENTING WAS PERCEIVED IN AN APPROPRIATE LOCATION ON THE FOSSA OVALE. DURING THE RF TRANSEPTAL PUNCTURE, IT WAS BELIEVED THAT THE DEVICE PUNCTURED THROUGH THE POSTERIOR WALL OF THE RIGHT ATRIUM. ECHO IMAGING WAS INDICATIVE OF AN APPROPRIATE TRAJECTORY AFTER RADIOFREQUENCY ENERGY WAS APPLIED, BUT THERE WAS NO ACCESS TO THE LEFT ATRIUM; IT WAS EVIDENT THAT THE SEPTUM WAS NOT CROSSED. A PERICARDIAL EFFUSION (PE) WAS THEN NOTED IN THE RIGHT ATRIUM. PERICARDIAL EFFUSION RESULTED IN >250CC OF BLOOD LOSS, AND A SIGNIFICANT DROP IN BLOOD PRESSURE AND HEART RATE. THE EFFUSION WAS ROUGHLY 0.59 CM, AFTER THE PROCEDURE, THE EFFUSION WAS NOTICEABLY LARGER. THEREFORE, THE PERICARDIOCENTESIS KIT WAS USED TO DRAIN THE EFFUSION. THE PATIENT COULD NOT BE STABILIZED, SO THEY WERE TRANSPORTED TO THE OPERATING ROOM (OR) FOR CT SURGERY AND BLOOD TRANSFUSION. THE PATIENT RECOVERED AND IS DOING WELL. SINCE THE INITIAL GROIN ACCESS, FORTY MINUTES PASSED UNTIL THE ISSUE WAS ENCOUNTERED. THIS PROCEDURE WAS CANCELLED. THE DEVICE WILL NOT BE RETURNED SINCE IT WAS DISCARDED AT THE FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 539793 | VERSACROSS CONNECT LAAC ACCESS SOLUTION | CATHETER, SEPTOSTOMY | DXF | BAYLIS MEDICAL COMPANY INC. | VXAK0003 | VMFA080123 | 00685447012573 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention| O |