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 PERFORMER; INTRODUCER, 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 PERFORMER; INTRODUCER, CATHETER Back to Search Results
Model Number G11672
Device Problems Fluid/Blood Leak (1250); Off-Label Use (1494)
Patient Problems Death (1802); Blood Loss (2597)
Event Date 10/31/2019
Event Type  Death  
Event Description
The sheath was used in an off-label fashion, which is typical, to facilitate stenting of multiple visceral vessels simultaneously.The multiple punctures allow for leakage, at a slow rate, around the puncture sites in the valve leaflets, as opposed to valve orifice.In this case, the 18 french sheath may have contributed to the patient's blood loss.
 
Event Description
The sheath was used in an off-label fashion, which is typical, to facilitate stenting of multiple visceral vessels simultaneously.The multiple punctures allow for leakage, at a slow rate, around the puncture sites in the valve leaflets, as opposed to valve orifice.In this case, the 18 french sheath may have contributed to the patient's blood loss.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PERFORMER
Type of Device
INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INCORPORATED
6300 n. matthews dr
ellettsville IN 47429
MDR Report Key9610773
MDR Text Key175687011
Report Number9610773
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/19/2019
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? Yes
Device Operator No Information
Device Model NumberG11672
Device Catalogue NumberRCFW-18.0P-38-30-RB
Device Lot Number9935834
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/19/2019
Event Location Hospital
Date Report to Manufacturer01/21/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/21/2020
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death; Life Threatening;
Patient Age23725 DA
-
-