inforMED
MalfunctionOFB

CATHETER GUIDE WIRE

Received Mar 15, 2019 · Event occurred Feb 22, 2019

Report 1220648-2019-00041 · MDR key 8425535

Device

Generic name

Catheter Guide Wire Kit

Manufacturer

Abiomed

Catalog number

0052-3005

Lot number

1085411

Product problems

  • Use of Device Problem
  • Device-Device Incompatibility
  • Separation Problem
  • Use of Device Problem
  • Device-Device Incompatibility
  • Separation Problem

Patient

60 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

THE COMPLAINANT DID RETURN THE PROXIMAL END OF THE 0.018" GUIDEWIRE, IMPELLA PUMP, THE ACCESSORY CABLE, 14FR INTRODUCER SHEATH, AND PURGE CASSETTE FOR ANALYSIS. THE FRACTURED PORTION OF THE GUIDEWIRE TIP WAS NOT RETURNED FOR ANALYSIS AS IT HAS YET TO BE LOCATED. THE DATA LOGS WERE NOT RETURNED, BUT THEY DO NOT PERTAIN TO THE FAILURE MODE. THE ANALYSIS AND EXAMINATION OF THE PRODUCT SHOWED AN INTERACTION BETWEEN THE IMPELLA PUMP'S REPOSITIONING UNIT AND THE GUIDEWIRE. THE GUIDEWIRE FRACTURE WAS DUE TO THE UNINTENTIONAL INSERTION OF THE PUMP REPOSITIONING UNIT INTO THE 14FR INTRODUCER, CAUSING INCREASED RESISTANCE DURING THE REMOVAL OF THE GUIDEWIRE. THE FRACTURE OF THE WIRE OCCURRED DUE TO THE EXCESSIVE FORCE APPLIED IN THE ATTEMPTED REMOVAL. A CAPA HAS BEEN OPENED TO ADDRESS THE GUIDEWIRE FAILURE MODE. FAILURES OF THIS TYPE WILL BE MONITORED AND TRENDED.

Description of Event or Problem

A (B)(6) YEAR OLD PATIENT WITH A CARDIAC HISTORY WAS ADMITTED AND FOUND TO HAVE MULTIVESSEL CORONARY ARTERY DISEASE AND SUFFERED A VF (VENTRICULAR FIBRILLATION) EPISODE IN THE CARDIAC CATHETERIZATION LAB. HE WAS HYPOTENSIVE AND IN NEED OF HEMODYNAMIC SUPPORT FOR THE PLANNED CORONARY ANGIOPLASTY, SO AN IMPELLA CP WAS TO BE INSERTED VIA THE RIGHT FEMORAL ARTERY. THE 14FR INTRODUCER WAS PLACED, THE IMPELLA CP INSERTED, AND THE TEAM THEN ATTEMPTED TO REMOVE THE 0.018" GUIDEWIRE FROM THE IMPELLA PUMP. UPON REMOVAL THE TEAM FELT RESISTANCE FROM THE WIRE AND THE WIRE FRACTURED. THE TIP OF THE GUIDEWIRE WAS NOT OBSERVED IN THE ILIOFEMORAL ANATOMY, AORTA, OR HEART'S LEFT VENTRICLE. THE TEAM PROCEEDED WITH THE ANGIOPLASTY AND SENT THE PATIENT TO THE ICU ON SUPPORT WITH THE IMPELLA CP PUMP. PRIOR TO TRANSFER TO THE ICU THE TEAM DID A FLUOROSCOPY AND AGAIN DID NOT VISUALIZE THE TIP OF THE GUIDEWIRE. THROUGHOUT HIS HOSPITAL STAY THE TEAM DID FLUOROSCOPY AND CT IMAGING AND TO DATE HAS NOT NOTIFIED ABIOMED OF THE LOCATION OR DISCOVERY OF THE GUIDEWIRE TIP. THE PATIENT IS STILL ON SUPPORT WITH AN IMPELLA PUMP.