ASAP® 00884450033005Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450033005), received between Aug 13, 2020 and Nov 11, 2020 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING AN EMERGENT PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY [PTCA] STEMI PROCEDURE, AN INTERVENTIONAL GUIDEWIRE BECAME STUCK WITHIN THE ASPIRATION CATHETER. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED RETROGRADE ARTERIAL ACCESS AND HAD NEGOTIATED THE PATIENT'S ASCENDING AORTA UNDER FLUOROSCOPY WITH THE ASPIRATION CATHETER . DURING ASPIRATION CATHETER MANIPULATIONS THE INTERVENTIONAL GUIDEWIRE BECAME STUCK WITHIN THE ASPIRATION CATHETER. THE PHYSICIAN WAS FORCED TO REMOVE ALL INTERVENTIONAL EQUIPMENT AND MAKE A SECOND ATTEMPT IN TREATING THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10825637 ↗
• InjuryAug 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING AND EMERGENT PERCUTANEOUS CARDIAC INTERVENTION [PCI], THE ASPIRATION CATHETER BECAME ENTANGLED WITHIN THE PATIENT'S RCA. THE PHYSICIAN HAD ACQUIRED RETROGRADE, ARTERIAL VASCULAR ACCESS AND WAS ATTEMPTING TO ASPIRATE TARGETED THROMBUS/CLOT IDENTIFIED WITHIN THE PATIENTS RIGHT CORONARY ARTERY [RCA]. THE PATIENT WAS HEMODYNAMICALLY UNSTABLE ON AND OFF THROUGHOUT THE PROCEDURE. THE FIRST ASPIRATION PASS WAS SUCCESSFUL BUT, DURING THE SECOND ASPIRATIONS PASS THE GUIDEWIRE HAD EXITED THE ASPIRATION CATHETER AND DURING CATHETER MANIPULATIONS THE GUIDE WIRE, GUIDE CATHETER AND ASPIRATION CATHETER BECAME ENTANGLED. THE PHYSICIAN REMOVED ALL INTERVENTIONAL EQUIPMENT AND HAD TO OPEN AND INTRODUCE NEW EQUIPMENT TO SUCCESSFULLY COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10403524 ↗