Byrd G19860Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002198609), received between Jun 19, 2024 and Dec 4, 2024 — classified as 1 death, 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 25NOV2024, PHILIPS JAPAN PROVIDED THE FOLLOWING INFORMATION REGARDING ADVERSE EVENTS OCCURRING DURING LEAD REMOVAL CASES. DEVICES USED: LR-PPLBES-10.0 (N204846) LR-PPLBES-11.5 (N201075) PHILIPS/GLIDELIGHT 14FR PHILIPS/GLIDELIGHT 16FR THIS WAS A LEAD EXTRACTION PROCEDURE FOR INFECTION. RV LEAD EXTRACTION WAS PROCEEDED USING A PHILIPS/GLIDELIGHT 14FR, A BYRD 10F (LR-PPLBES-10.0), AND A BYRD 11.5F (LR-PPLBES-11.5). PHILIPS/GLIDELIGHT 14FR AND THE OUTER HAD BEEN ADVANCED FROM NEAR THE TRICUSPID VALVE, BUT THE OUTER DID NOT ADVANCE PROPERLY A FEW CENTIMETERS BEFORE THE TIP OF THE LEAD, SO GLIDELIGHT 14FR WAS CHANGED TO A GLIDELIGHT 16FR. THE GLIDELIGHT 16FR WAS ADVANCED, AND THE LASER WAS IRRADIATED FOR 1 SECOND A FEW CENTIMETERS BEFORE THE TIP OF THE LEAD. THE GLIDELIGHT 16FR WAS REMOVED WITHOUT FURTHER LASER IRRADIATION, BUT AT THE MOMENT OF REMOVAL, FLUOROSCOPY SHOWED THAT THE GLIDELIGHT HAD ADVANCED SEVERAL CM TOWARD THE CARDIAC APEX. IMMEDIATELY AFTER REMOVAL OF THE GLIDELIGHT 16FR, PERICARDIAL EFFUSION AND A DROP IN BLOOD PRESSURE WERE CONFIRMED. THE CARDIOVASCULAR SURGERY DEPARTMENT WAS CONTACTED, AND EMERGENCY ECMO, THORACOTOMY, AND RIGHT VENTRICULAR REPAIR WERE PERFORMED. TH

  Patient problems: Cardiac Perforation; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 20843219 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ANATOMY BEFORE SURGERY AND AT THE TIME OF FAILURE: A PACEMAKER GENERATOR HAD BEEN IMPLANTED IN THE LEFT CHEST, AND PACEMAKER LEADS HAD BEEN PLACED FROM THE LEFT SUBCLAVIAN VEIN TO THE RIGHT ATRIUM AND RIGHT VENTRICLE RESPECTIVELY. APPROACHED FROM THE LEFT SUBCLAVIAN VEIN TO THE RIGHT ATRIUM. AFTER THE ATRIAL LEAD WAS REMOVED, BLOOD PRESSURE DROPPED WHEN THEY TRIED TO ACCESS THE VENTRICULAR LEAD. WHEN THE PATIENT'S CHEST WAS OPENED, DAMAGE TO THE ATRIUM WAS FOUND, WHICH WAS TREATED SURGICALLY. THE PATIENT WAS ADMITTED TO THE ICU AND IS CURRENTLY RECOVERING.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Perforation

  MAUDE report 19566472 ↗