Performa® 00884450004265Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450004265), received between Nov 7, 2019 and Nov 27, 2019 — classified as 3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2019Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AND PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY [PTCA] PROCEDURE, THE (B)(6)-YEAR-OLD PATIENT CODED AND EXPIRED. THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL ACCESS TO SUCCESSFULLY DEPLOY A CORONARY STENT. DURING THE PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE RENAL ARTERY BRANCH. THE PHYSICIAN ATTEMPTED UNSUCCESSFULLY TO REMOVE THE DETACHED CATHETER TIP FROM THE PATIENT. A RENAL ULTRASOUND WAS ORDERED AND COMPLETED SUCCESSFULLY. THE PATIENT BECAME HYPOTENSIVE, THE PHYSICIAN ADMINISTERED NORADRENALIN TO INCREASE THE PATIENTS' BLOOD PRESSURE / VOLUME. THE EKG DEMONSTRATED ST-ELEVATION AND VENTRICULAR TACHYCARDIA ARRHYTHMIA. THE PHYSICIAN URGENTLY PERFORMED AN ADDITIONAL ANGIOGRAM ATTEMPTING TO IDENTIFY THE CULPRIT OCCLUSION. ACUTE STENT THROMBOSIS WAS EVIDENT. THE PATIENT CODED AND ACLS PROTOCOL WAS DIRECTED FOR APPROXIMATELY 35MIN. SUDDEN CARDIAC ARREST (SCA) WAS CONFIRMED.

  Patient problems: Death

  MAUDE report 9385085 ↗
• InjuryNov 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING A SELECTIVE CORONARY ANGIOGRAM [SCA], THE CATHETER TIP DISSECTED THE OSTIUM OF THE RIGHT CORONARY ARTERY [RCA] DURING DIAGNOSTIC CATHETER MANIPULATIONS OVER A GUIDE WIRE. THE PHYSICIAN SUCCESSFULLY COVERED AND TREATED THE DISSECTION BY DEPLOYING A DRUG ELUTING SENT [DES] WITHIN THE PATIENT'S RCA. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: Atrial Perforation

  MAUDE report 9292657 ↗
• InjuryNov 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING A SELECTIVE CORONARY ANGIOGRAM [SCA], THE CATHETER TIP DISSECTED THE OSTIUM OF THE RIGHT CORONARY ARTERY [RCA] DURING DIAGNOSTIC CATHETER MANIPULATIONS OVER A GUIDE WIRE. THE PHYSICIAN SUCCESSFULLY COVERED AND TREATED THE DISSECTION BY DEPLOYING A DRUG ELUTING SENT [DES] WITHIN THE PATIENT'S RCA. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: Atrial Perforation

  MAUDE report 9292655 ↗