QUATTRO® Intravascular Heat Exchange Catheter Applause Custom Luer IC-4593CORecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849111075534), received between Sep 14, 2017 and Sep 14, 2017 — classified as 1 death.

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 18, 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.

• DeathSep 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SUBJECT (A (B)(6) FEMALE) ENROLLED IN A CASE SERIES CLINICAL STUDY, EXPERIENCED A NON-ANTERIOR ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI) ON (B)(6) 2017 AT 09:15, AND AT 11:15 THE EMS BROUGHT THE SUBJECT TO THE HOSPITAL. HER ECG AT ADMISSION SHOWED NORMAL SINUS RHYTHM AND WAS ABNORMAL FOR NON-ANTERIOR STEMI. HER VITAL SIGNS WERE HEART RATE 77 BEATS/MIN, BLOOD PRESSURE 160/60 MMHG, RESPIRATORY RATE 16 BREATHS/MIN, AND TYMPANIC TEMPERATURE 35.8°C. THE SUBJECT PAST MEDICAL HISTORY WAS REMARKABLE FOR CURRENT HYPERTENSION, CORONARY ARTERY DISEASE, AND DIABETES MELLITUS CONTROLLED BY DIET AND ORAL MEDICATIONS. THE SUBJECT DID NOT REPORT ANY SURGICAL MEDICAL HISTORY. SHE NEVER USED TOBACCO AND DID NOT USE ALCOHOLIC BEVERAGES (LESS THAN 1 DRINK PER YEAR). ON (B)(6) 2017 AT 11:25, THE SUBJECT SIGNED (B)(6) STUDY CONSENT FORM AND WAS ENROLLED INTO THE (B)(6) STUDY. ANTISHIVERING MEDICATIONS BUSPIRONE AND PETHIDINE WERE ADMINISTERED AFTER ENROLLMENT BEFORE COOLING PER THE STUDY PROTOCOL. THE TOTAL VOLUME OF 2.0 L OF 4°C NORMAL SALINE WAS INFUSED FROM 11:34 TO 11:58. THE SUBJECT ARRIVED AT CATHETERIZATION LABORATORY ON (B)(6) 2017 AT 11:30. DIAGNOSTIC ANGIOGRAM W

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6865997 ↗