• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE

  • 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
 

MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE Back to Search Results
Model Number 4FC12
Device Problems Fluid Leak (1250); Leak/Splash (1354); Aspiration Issue (2883)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/11/2016
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
This event occurred outside the us where the same model is distributed. All information provided is included in this report. Patient information is not generally available due to confidentiality concerns. (b)(4).
 
Event Description
It was reported that during a cryoablation procedure, fluid dripped out of the sheath. While aspirating, air was sucked into the syringe. The sheath was immediately replaced and the procedure was completed with cryo. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Event summary: the patient data files did not show any issues. Upon visual inspection of the flexcath sheath 4fc12 / 28803-92 showed many kinks on the flexcath shaft. The shaft is kinked at 2. 09, 3. 69, 6. 09, and 9. 86 centimeters from the tip of the flexcath as well as at the base of the strain relief. Air aspiration was reproduced when a test arctic front catheter was introduced through the sheath. Dissection showed the hemostatic valve was leaking; the valve was torn. In conclusion, the reported issue (air ingress) has been confirmed through testing. The sheath failed the returned product inspection due to a leaking hemostatic valve and many kinks on shaft.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFLEXCATH ADVANCE STEERABLE SHEATH
Type of DeviceCATHETER, STEERABLE
Manufacturer (Section D)
MEDTRONIC CRYOCATH LP
16771 chemin ste-marie
kirkland H9H 5 H3
CA H9H 5H3
Manufacturer (Section G)
MEDTRONIC CARDIAC RHYTHM HEART FAILURE
8200 coral sea st ne
mounds view MN 55112
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key5455079
MDR Text Key104703959
Report Number3002648230-2016-00058
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/29/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/29/2017
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number28803
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/24/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/30/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-