Worley™ Adv. LVI 00884450483954Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450483954), received between Oct 28, 2025 and Oct 28, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionOct 28, 2025Break; Fracture; Material Separation; Material Integrity Problem; Break; Fracture; Material Separation; Material Integrity Problem

  THE ACCOUNT ALLEGES THAT DURING PLACEMENT OF A DUAL ACCESS INTRODUCER (DAI-TRC), WHILE ADVANCING THE WORLEY ADVANCED SELECTIVE INTRODUCER TOWARD THE CORONARY SINUS TRIBUTARY, THE DISTAL TIP OF THE DEVICE DETACHED. AN AMPLATZ GOOSE NECK SNARE SYSTEM WAS INTRODUCED TO CAPTURE THE DETACHED SEGMENT. DURING RETRIEVAL, THE TIP FRAGMENTED FURTHER, AND ONE PORTION MIGRATED TOWARD THE PULMONARY ARTERY. DUE TO THE RISK OF ADDITIONAL FRAGMENTATION AND POTENTIAL VESSEL INJURY, RETRIEVAL EFFORTS WERE DISCONTINUED, AND TWO FRAGMENTS OF THE WORLEY INTRODUCER TIP WERE LEFT IN SITU. FOLLOWING THE EVENT, THE PHYSICIAN NOTED THAT A RETAINED FRAGMENT IN THE CORONARY SINUS CAUSED THROMBOSIS OF A CORONARY SINUS TRIBUTARY, AND ANOTHER FRAGMENTED PORTION HAD MIGRATED INTO THE SEGMENTAL PULMONARY ARTERY, POSING A RISK FOR THROMBOSIS. THE PATIENT WAS PLACED ON LIFELONG ANTICOAGULATION THERAPY. THE PROCEDURE WAS PERFORMED VIA A VENOUS APPROACH.

  Patient problems: Foreign Body In Patient; Thrombosis/Thrombus

  MAUDE report 23405387 ↗