Worley™ Adv. LVI 00884450284650Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450284650), received between Jun 1, 2021 and Jun 1, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A CARDIAC RESYNCHRONIZATION THERAPY (CRT) PROCEDURE, A VEIN SELECTOR CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED SUCCESSFUL ANTEGRADE VENOUS ACCESS VIA THE SUBCLAVIAN VEIN. A GENERATOR POCKET WAS FASHIONED WITHIN THE INFRACLAVICULAR AREA PARALLEL TO THE MIDDLE THIRD OF THE PATIENT'S CLAVICLE, THE GUIDEWIRE WAS THEN INTRODUCED UNDER FLUOROSCOPY, AND THE VEIN SELECTOR WAS INTRODUCED FOR TARGETED VEIN SELECTION. THE ANTERIOR LATERAL VESSEL WAS SUCCESSFULLY SELECTED. DURING MANIPULATIONS FOR PACEMAKER LEAD PURCHASE, THE TIP OF THE VEINOUS SELECTOR DETACHED WITHIN THE PATIENT'S CORONARY SINUS BUT REMAINED ON THE GUIDEWIRE. THE PHYSICIAN SUCCESSFULLY REMOVED THE FOREIGN BODY FROM THE PATIENT WITH A 2MM CORONARY BALLOON. THE CRT PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11916467 ↗