Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INCORPORATED LIBERATOR LOCKING STYLET; STYLET, CATHETER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOK INCORPORATED LIBERATOR LOCKING STYLET; STYLET, CATHETER Back to Search Results
Patient Problems Low Blood Pressure/ Hypotension (1914); Internal Organ Perforation (1987); Cardiac Tamponade (2226)
Event Date 09/20/2023
Event Type  Injury  
Event Description
Lead traction: cook liberator on ra(right atrial) lead, cook liberator and one-tie on rv(right ventricular) lead.(b)(6) 14f glidelight laser sheath was used to advance on rv lead, then 12f glidelight advanced on ra lead.14f glidelight was used again to further advance on rv lead.Then 13f byrd sheath was used to advance on rv lead.Lastly, 16f glidelight was used on rv lead, and lead was extracted.Patient's blood pressure dropped, and rescue efforts began, including noradrenaline and thoracotomy.A coronary sinus perforation was discovered and repaired, and then the ra lead was removed post-thoracotomy.It was confirmed that the 16f glidelight was not used to lase at the coronary sinus or the coronary sinus os.The physician suspected that upon initial implant, the rv lead had prolapsed into the middle cardiac vein (mcv), and the lead's distal tip had bound up on the vessel wall.With countertraction, the lead's tip injured the mcv, and cardiac tamponade developed.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).Ref report: mw5147235.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LIBERATOR LOCKING STYLET
Type of Device
STYLET, CATHETER
Manufacturer (Section D)
COOK INCORPORATED
MDR Report Key17984999
MDR Text Key326299907
Report NumberMW5147234
Device Sequence Number1
Product Code DRB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 10/12/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/20/2023
Patient Sequence Number1
Treatment
12F GLIDE LIGHT; 13F BYRD SHEATH; 13F BYRD SHEATH; COOK MEDICAL ONE-TIE COMPRESSION COIL; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH
Patient Age25 YR
Patient SexFemale
-
-