CRISTA CATH D7A20131RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835005042), received between Oct 24, 2022 and Aug 21, 2024 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) ABLATION PROCEDURE WITH A WEBSTER CS AND A CRISTA CATH AND THE PATIENT EXPERIENCED CARDIAC ARREST AND HEMORRHAGE THAT RESULTED IN DEATH. THE PATIENTS PRESSURE DROPPED SIGNIFICANTLY DURING TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PRIOR TO TRANSEPTAL PUNCTURE. AFTER THIS WAS NOTICED, CARDIOPULMONARY RESUSCITATION (CPR) WAS ADMINISTERED. THE PATIENTS' PRESSURE WOULD RECOVER SLIGHTLY AND THEN FALL AGAIN - ALL WHILE GOING IN AND OUT OF VENTRICULAR TACHYCARDIA (VT). PATIENT WAS SHOCKED BACK INTO NORMAL RHYTHM WHEN NEEDED. INTERVENTIONAL RADIOLOGY (IR) WAS CALLED TO CHECK FOR AORTIC AND RETROPERITONEAL BLEED WITH NO FINDINGS. CARDIO VASCULAR (CV) SURGERY WAS CALLED AND PLACED THE PATIENT ON ECMO. THE PATIENT WAS STABLE AND ON ECMO AND THEN SHORTLY AFTER THE PATIENT STARTED TO CODE. CV SURGERY, IR AND EPS WERE ALL IN THE ROOM ATTEMPTING TO FIGURE OUT THE PROBLEM. IT WAS NOTICED THE PATIENT¿S ABDOMEN WAS DISTENDED. PHYSICIANS SURGICALLY OPENED THE BELLY AND FOUND THE ABDOMEN WAS FULL OF BLOOD. AFTER A LONG-STANDING EFFORT, ANESTHESIA SAID THE PUPILS WERE NON-REACTIVE AND BLOWN. THE CAUSE OF THE BLEED REMAINS UNK

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20019351 ↗
• MalfunctionOct 24, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN UNKNOWN ABLATION PROCEDURE WITH A CRISTA CATH¿ ELECTROPHYSIOLOGY CATHETER. THE STERILE PACKAGING LOOKED PARTIALLY UNSEALED WHICH COMPROMISED THE PROTECTION OF THE CATHETER. THE STERILE PACKAGING LOOKED PARTIALLY UNSEALED WHICH COMPROMISED THE PROTECTION OF THE CATHETER. THERE WERE NO PATIENT CONSEQUENCES. OPEN POUCH SEAL IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15656949 ↗