Performa® 00884450005187Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450005187), received between Oct 25, 2019 and Oct 25, 2019 — classified as 3 injuries.

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

• InjuryOct 25, 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 CONTROLLED THE DISSECTION BY DEPLOYING A DRUG ELUTING SENT [DES] WITHIN THE PATIENT'S RCA. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: Intimal Dissection

  MAUDE report 9242435 ↗
• InjuryOct 25, 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 CONTROLLED THE DISSECTION BY DEPLOYING A DRUG ELUTING SENT [DES] WITHIN THE PATIENT'S RCA. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: Intimal Dissection

  MAUDE report 9242434 ↗
• InjuryOct 25, 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 CONTROLLED THE DISSECTION BY DEPLOYING A DRUG ELUTING SENT [DES] WITHIN THE PATIENT'S RCA. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: Intimal Dissection

  MAUDE report 9242433 ↗