Performa® 00884450002919Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450002919), received between Jan 18, 2023 and May 11, 2023 — classified as 2 injuries.

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 16, 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.

• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING AN URGENT CORONARY ANGIOGRAPHY [STEMI] PROCEDURE ON A 32 YO PATIENT, IT WAS REVEALED THERE WAS A PARTIAL DISSECTION OF THE LEFT MAIN TRIFURCATION INVOLVING THE RIA, RIM , AND RCX ARTERIES. THIS RESULTED IN TOTAL OBSTRUCTION OF THE RAMUS INTERMEDIATE MAMMARY [RIM] AND THE RIGHT CORONARY [RC] ARTERIES. THE PATIENT SUFFERED FROM CARDIOGENIC SHOCK AND INCREASED HEART RATE DURING THIS PROCEDURE. IT CANNOT BE DETERMINED WHETHER THE CORONARY DISSECTION WAS PURELY IATROGENIC OR SPONTANEOUS IN NATURE. IMMEDIATE PCI AND RECONSTRUCTION OF THESE ARTERIES SUCCESSFULLY TOOK PLACE UTILIZING FIVE DRUG-ELUDING STENTS [DES] RESULTING IN THE RESTORATION OF CORONARY PERFUSION, HEMODYNAMIC STABILIZATION, AND AN ACCEPTABLE HEART RATE. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 16911282 ↗
• InjuryJan 18, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT [TIPSS] PROCEDURE. THE PHYSICIAN HAD ACQUIRED VENOUS ACCESS VIA THE INTERNAL JUGULAR VEIN WITH A 10F SHEATH. DURING MANIPULATIONS OVER A STIFF GUIDEWIRE UNDER FLUOROSCOPY, THE CATHETER TIP DETACHED. THE TIP REMAINED ON THE GUIDE WIRE. THE PHYSICIAN WAS ABLE TO REMOVE BOTH THE DETACHED CATHETER TIP AND GUIDEWIRE TOGETHER AS ONE UNIT. NO ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THE EVENT WAS NOT CONSIDERED LIFE-THREATENING BY THE ATTENDING PHYSICIAN. NO PERMANENT DAMAGE TO BODY FUNCTION OR STRUCTURE TO REPORT. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16195344 ↗