Performa® 00884450000960Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450000960), received between Sep 30, 2020 and Sep 30, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• InjurySep 30, 2020Difficult to Remove; Difficult to Remove

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY BYPASS ANGIOPLASTY [PTCA] PROCEDURE, THE CATHETER BECAME KINKED WITHIN THE PATIENT. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED RETROGRADE ARTERIAL ACCESS AND HAD NEGOTIATED THE PATIENT'S VASCULATURE UNDER FLUOROSCOPY WITH THE 5F DIAGNOSTIC CATHETER TO CANNULATE AND OPACIFY THE NATIVE CORONARY ARTERIES/GRAFTS. WHEN THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE CATHETER POST LEFT HEART DIAGNOSTIC PROCEDURE, THE CATHETER KINKED. THE CARDIOLOGIST UNSUCCESSFUL IN REMOVING THE CATHETER FORM THE PATIENT. A RADIOLOGIST WAS CONSULTED TO ASSIST WITH THE FOREIGN BODY REMOVAL. THE RADIOLOGIST ACQUIRED SECONDARY ACCESS VIA RIGHT FEMORAL ARTERY WITH A 7F SHEATH. A VASCULAR SNARE DEVICE WAS USED TO SUCCESSFULLY CAPTURE THE RETRIEVE THE DAMAGED CATHETER FROM THE PATIENT. POST-PROCEDURE THE PATIENT SUFFERED AN UNRELATED CARDIAC ARREST EVENT AND WAS SUCCESSFULLY RESUSCITATED BY THE MEDICAL STAFF. PROLONGATION OF HOSPITALIZATION WAS DEEMED NECESSARY BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10610046 ↗