COOK G47468Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002474687), received between Jun 21, 2023 and Jun 21, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Off-Label Use” (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 16, 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.

• MalfunctionJun 21, 2023Off-Label Use; Physical Resistance/Sticking; Off-Label Use; Physical Resistance/Sticking

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ZDEG TRIGGER WIRE RELEASE MECHANISM WOULD NOT RELEASE FROM DEVICE. TRIGGER WIRES COULD NOT INITIALLY BE REMOVED AFTER FULLY UNSHEATHING ZDEG INSIDE THE THORACIC AORTA. UNABLE TO CONFIRM NOR DENY THAT THE TRIGGER WIRE RELEASE MECHANISM HAD NOT BEEN ROTATED PRIOR TO ATTEMPTING TO REMOVE FROM TRIGGER WIRES. PHYSICIAN WAS ABLE TO PRY MECHANISM APART ENOUGH TO RELEASE WIRES AND SUCCESSFULLY DEPLOY THE DEVICE. ADDITIONAL INFORMATION RECEIVED (B)(6)2023 : THE PHYSICIANS DID USE (B)(4) SETS OF FORCEPS TO CORRECT THE STUCK RELEASE MECHANISM, BUT NOT TO PHYSICALLY REMOVE THE TRIGGER WIRES. THE TEAM ACTUALLY USED THE FORCEPS TO TRY AND SPREAD THE GREEN TRIGGER MECHANISM APART IN AN EFFORT TO ACCESS THE WIRES. THEY BROKE BOTH FORCEPS IN THE PROCESS. ALTHOUGH THE SCRUB TEAM SAID THE DOCTOR ALSO ¿BEAT THE DEVICE A LOT¿ MEANING THE GREEN MECHANISM. THE PHYSICAL MANIPULATION OF THE MECHANISM WAS ENOUGH TO RELEASE ENOUGH TENSION AND THE TEAM WAS ABLE TO REMOVE THE MECHANISM WITH ALL WIRES INTACT. THE ONLY WIRE THAT LOOKED DAMAGED WAS THE STAINLESS STEEL WIRE, WHICH WAS BENT IN A 90 DEGREE ANGLE. PATIENT OUTCOME: THE GRAFT WAS FULLY DEPLOYED AND LA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17168969 ↗