OPTITORQUE 40-5021Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04987350700063), received between Dec 4, 2019 and Dec 10, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE USER FACILITY REPORTED THAT THERE WAS A RED FOREIGN MATTER WAS OBSERVED IN THE HUB OF THE INVOLVED NEEDLE K-PACK II 30GX 1/2''-0,3X12MM-THIN WALL-SHORT CASE. THERE WAS NO HARM TO THE PATIENT. THE EVENT OCCURRED PRE-TREATMENT. ADDITIONAL INFORMATION WAS RECEIVED ON 19NOV2019. ONE CASE HAPPENED AMONG 90,000 PIECES. ADDITIONAL INFORMATION WAS RECEIVED ON 22NOV2019. THERE WAS NO DELAY, NO IMPACT ON PATIENT OR USER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9443400 ↗
• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT THE INVOLVED OPTITORQUE ANGIOGRAPHIC CATHETER DEVICE DID NOT FAIL; HOWEVER, PATIENT INJURY OCCURRED. THIS PHYSICIAN WAS PERFORMING A RADIAL LEFT HEART CATHETERIZATION. HE ALWAYS USES THE JACKY CATH FOR THE LEFT VENTRICULAR ANGIOGRAM (LV GRAM) AS WELL AS IMAGING THE CORONARY ARTERIES. WHILE INJECTING THROUGH THE CATH FOR THE LV GRAM, THE MYOCARDIUM CAME IN CONTACT WITH THE TIP OF THE CATH DURING A SYSTOLIC CONTRACTION. THE POWER OF THE INJECTION BROKE THROUGH THE MYOCARDIUM AND FILLED THE PERICARDIAL SPACE WITH CONTRAST. THE WALL OF THE LV WAS COMPROMISED AND REQUIRED IMMEDIATE ATTENTION. A PERICARDIOCENTESIS WAS PERFORMED AND THEN THE PATIENT WAS LATER TAKEN TO THE OPERATING ROOM. THE SURGEON OPENED THE ANTERIOR CHEST WALL AND PLACED A SINGLE SUTURE TO CLOSE THE COMPROMISED MYOCARDIUM. THE PATIENT DID FINE WITH THE SURGERY AND WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT FOR RECOVERY. A POWER INJECTOR WAS USED FOR THE LV INJECTION. THE SETTING WAS AT A FLOW RATE OF 10CC PER SECOND, FOR A TOTAL OF 20CC DELIVERED. THE PSI LIMIT WAS AT 1000. AN ACCURATE ESTIMATE OF BLOOD LOSS COULD NOT BE PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 08NOV2019. TH

  Patient problems: Blood Loss

  MAUDE report 9411309 ↗
• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT THE INVOLVED OPTITORQUE ANGIOGRAPHIC CATHETER DEVICE DID NOT FAIL; HOWEVER, PATIENT INJURY OCCURRED. THIS PHYSICIAN WAS PERFORMING A RADIAL LEFT HEART CATHETERIZATION. HE ALWAYS USES THE JACKY CATH FOR THE LEFT VENTRICULAR ANGIOGRAM (LV GRAM) AS WELL AS IMAGING THE CORONARY ARTERIES. WHILE INJECTING THROUGH THE CATH FOR THE LV GRAM, THE MYOCARDIUM CAME IN CONTACT WITH THE TIP OF THE CATH DURING A SYSTOLIC CONTRACTION. THE POWER OF THE INJECTION BROKE THROUGH THE MYOCARDIUM AND FILLED THE PERICARDIAL SPACE WITH CONTRAST. THE WALL OF THE LV WAS COMPROMISED AND REQUIRED IMMEDIATE ATTENTION. A PERICARDIOCENTESIS WAS PERFORMED AND THEN THE PATIENT WAS LATER TAKEN TO THE OPERATING ROOM. THE SURGEON OPENED THE ANTERIOR CHEST WALL AND PLACED A SINGLE SUTURE TO CLOSE THE COMPROMISED MYOCARDIUM. THE PATIENT DID FINE WITH THE SURGERY AND WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT FOR RECOVERY. A POWER INJECTOR WAS USED FOR THE LV INJECTION. THE SETTING WAS AT A FLOW RATE OF 10CC PER SECOND, FOR A TOTAL OF 20CC DELIVERED. THE PSI LIMIT WAS AT 1000. AN ACCURATE ESTIMATE OF BLOOD LOSS COULD NOT BE PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 08NOV2019. TH

  Patient problems: Blood Loss

  MAUDE report 9411307 ↗