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Inquiry™ IBI-81473Recalls & reported problems

Irvine Biomedical, Inc. · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734304313), received between Jun 20, 2018 and Jun 20, 2018 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Cardiac Perforation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    DURING A CRT-D IMPLANT PROCEDURE, A CARDIAC PERFORATION OCCURRED. AFTER INSERTING THE CATHETER TO ASSIST DURING CANNULATION OF THE CORONARY SINUS (CS), CONTRAST MEDIA WAS INJECTED AND OBSERVED IN THE PERICARDIUM. X-RAY REVEALED A PUNCTURE NEAR THE MID CS REGION. THE PATIENT BECAME HYPOTENSIVE AND WAS TREATED WITH FLUIDS, MEDICATION AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZED THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY (B)(4) DEVICE.

    Patient problems: Cardiac Perforation

    MAUDE report 7619335 ↗

Other CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING devices

All CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.