Lunderquist G53971Recalls & reported problems
William Cook Europe ApS · Lunderquist, Extra Stiff DC Wire Guide · Class 2
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002539716), received between Dec 17, 2018 and Mar 23, 2022 — classified as 1 death, 1 malfunction.
The most frequently reported specific device problem is “Activation, Positioning or Separation 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
Device problems
- Activation, Positioning or Separation Problem1
- Positioning Problem1
Patient problems
- Low Blood Pressure/ Hypotension1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
DeathMar 23, 2022Positioning Problem; Positioning Problem
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: AFTER AN APPROACH FROM THE RIGHT FEMORAL ARTERY WAS GAINED WITH THE FIRST TSCMG-35-300-E-LESDC(E4202485), THE TWO ZENITH THORACIC ALPHA (ZTA-PT-36-32-209-W1/E4055076 AND ZTA-PT-32-28-201-W1/E4211066) WERE PLACED FROM JUST BELOW THE LEFT COMMON CAROTID ARTERY TO JUST ABOVE THE CELIAC ARTERY (FOR THE PRIMARY ENTRY CLOSURE). THEREAFTER, THE TWO ENDURANT II AORTIC EXTENSIONS WERE PLACED IN THE ABDOMINAL AORTA (FOR RE-ENTRY CLOSURE). DUE TO ALLERGY TO CONTRAST MEDIA, IVUS (INTRAVASCULAR ULTRASOUND) WAS USED TO CONFIRM THE POSITION OF THE BRANCHES. FOUR OF THE ABOVE STENT GRAFTS WERE IMPLANTED IN THE PLANNED POSITION. DUE TO THE NARROWING OF THE TRUE LUMEN OF THE DESCENDING AORTA, THERE WAS A NEED TO ENHANCE THE FITTING OF THE THORACIC ALPHA JUNCTION. SO, AFTER AN APPROACH FROM THE LEFT FEMORAL ARTERY WAS GAINED WITH THE SECOND TSCMG-35-300-E-LESDC(E4202485), TOUCH UP WITH A CODA BALLOON (CODA-2-10.0-35-120-40/14095690) WAS PLANNED TO BE PERFORMED. AN APPROACH FROM LEFT FEMORAL ARTERY WAS GAINED, THE REPORTED CODA BALLOON CATHETER COULD NOT BE ADVANCED DUE TO HIGH DEGREE OF TORTUOSITY OF DESCENDING AORTA,. INJURY/TEAR (RUPTURE) OCCURRED
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 13859837 ↗MalfunctionDec 17, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8168497 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.