VENTURE IPN914115Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841156102241), received between Aug 28, 2019 and Aug 28, 2019 — classified as 2 deaths.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

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.

• DeathAug 28, 2019Use of Device Problem; Use of Device Problem

  SITE REPORTED THERE WAS A DIFFICULT LESION IN THE LEFT MAIN CORONARY ARTERY, AND SIGNIFICANTLY ANGLED LAD. PHYSICIAN ATTEMPTED ACCESS TO THE LAD WITH MULTIPLE CATHETERS AND THEN ATTEMPTED WITH VENTURE BUT WAS UNSUCCESSFUL. SITE REPORTED IN TRYING DIFFICULT NAVIGATION VENTURE MAY HAVE HOOKED OR PENETRATED A VESSEL LAYER AND CAUSED A DISSECTION, UNSURE FROM IMAGING IF IT WAS A TRUE DISSECTION. THE PATIENT WAS SENT TO EMERGENT CABG AND EXPIRED 2 DAYS AFTER EMERGENT CABG. USER IDENTIFIED UNFAMILIARITY WITH THE CATHETER AS CONTRIBUTORY CAUSE. PER MEDWATCH UF/IMPORTER REPORT # (B)(4) SUBMITTED ON 05AUG19 TO FDA FROM SITE: (B)(6) YO MALE ADMITTED ON (B)(6) WITH NSTEMI, UNDERWENT CARDIAC CATH (B)(6) SHOWING TOTAL OCCLUSION OF RCA AND 70% OCCLUSION OF LAD. PT AND FAMILY DECIDED TO PURSUE PCI VERSUS CABG. ON (B)(6) PT UNDERWENT 2ND CATH FOR STENT DEPLOYMENT. ATTEMPT TO WIRE THE LAD WAS UNSUCCESSFUL, RESULTING IN ATTEMPT TO ACCESS THE VESSEL USING THE VENTURE CATHETER. AT THIS TIME THE PATIENT DECOMPENSATED, AND IT WAS DETERMINED THAT THE LAD WAS DISSECTING. PT REQUIRED PRESSURES AND BRIEF CPR. HE WAS TAKEN EMERGENTLY TO THE OR FOR A SALVAGE CABG. ALSO, CONCERN FOR A DEVELOPMENT OF A THROMBUS

  Patient problems: Death; Vascular Dissection

  MAUDE report 8941210 ↗
• DeathAug 28, 2019Use of Device Problem; Use of Device Problem

  SITE REPORTED THERE WAS A DIFFICULT LESION IN THE LEFT MAIN CORONARY ARTERY, AND SIGNIFICANTLY ANGLED LAD. PHYSICIAN ATTEMPTED ACCESS TO THE LAD WITH MULTIPLE CATHETERS AND THEN ATTEMPTED WITH VENTURE BUT WAS UNSUCCESSFUL. SITE REPORTED IN TRYING DIFFICULT NAVIGATION VENTURE MAY HAVE HOOKED OR PENETRATED A VESSEL LAYER AND CAUSED A DISSECTION, UNSURE FROM IMAGING IF IT WAS A TRUE DISSECTION. THE PATIENT WAS SENT TO EMERGENT CABG AND EXPIRED 2 DAYS AFTER EMERGENT CABG. USER IDENTIFIED UNFAMILIARITY WITH THE CATHETER AS CONTRIBUTORY CAUSE. PER MEDWATCH UF/IMPORTER REPORT # (B)(4) SUBMITTED ON 05AUG19 TO FDA FROM SITE: (B)(6) YO MALE ADMITTED ON (B)(6) WITH NSTEMI, UNDERWENT CARDIAC CATH (B)(6) SHOWING TOTAL OCCLUSION OF RCA AND 70% OCCLUSION OF LAD. PT AND FAMILY DECIDED TO PURSUE PCI VERSUS CABG. ON (B)(6) PT UNDERWENT 2ND CATH FOR STENT DEPLOYMENT. ATTEMPT TO WIRE THE LAD WAS UNSUCCESSFUL, RESULTING IN ATTEMPT TO ACCESS THE VESSEL USING THE VENTURE CATHETER. AT THIS TIME THE PATIENT DECOMPENSATED, AND IT WAS DETERMINED THAT THE LAD WAS DISSECTING. PT REQUIRED PRESSURES AND BRIEF CPR. HE WAS TAKEN EMERGENTLY TO THE OPERATING ROOM FOR A SALVAGE CABG. ALSO, CONCERN FOR A DEVELOPMENT O

  Patient problems: Death; Vascular Dissection

  MAUDE report 8941072 ↗