| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-11-11 | 0 |
Patient 1
DATE OF EVENT: EVENT OCCURRED SOMETIME IN (B)(6) 2019. OCCUPATION: RISK MANAGER. REPORT SOURCE: FDA 3500A 3600840000-2019-8016. PMA/510(K) #: EXEMPT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
Patient 1
IT WAS REPORTED THAT AFTER A PIGTAIL INSERTION FOR LARGER RIGHT SIDED PLEURAL EFFUSION, A GUIDE WIRE IN THE WAYNE PNEUMOTHORAX TRAY STRIPPED APART. AN (B)(6) YEAR OLD MALE PRESENTED WITH A LARGE, RIGHT-SIDED PLEURAL EFFUSION ON THE FIRST POST-OPERATIVE DAY FOR A CORONARY ARTERY BYPASS GRAFTING (CABG) AND AORTIC VALVE REPLACEMENT. WHEN THE GUIDE WIRE WAS BEING PULLED OUT OF THE PIGTAIL CHEST TUBE, IT BECAME STUCK WITHIN THE CATHETER. WHEN THE DOCTOR PULLED THE GUIDE WIRE HARDER, IT "STRIPPED APART". THE ENTIRE CHEST TUBE WAS REMOVED, AND AN X-RAY CONFIRMED THAT THE DEVICE WAS REMOVED INTACT FROM THE PATIENT AFTER THE WIRE HAD STRIPPED. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION REGARDING PATIENT AND EVENT DETAILS HAVE BEEN REQUESTED, BUT HAVE NOT BEEN MADE AVAILABLE AT THE TIME OF THIS REPORT.