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U.S. Department of Health and Human Services

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

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MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE Back to Search Results
Model Number 4FC12
Device Problems Air Leak (1008); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/15/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a cryo ablation procedure, while checking the intracardiac potential, a competitor device was inserted into the sheath, and when negative pressure was applied using the syringe from the side port of the sheath, air was introduced continuously. It was suspected to be a hemostatic valve issue, and the sheath was replaced. The case was completed with cryo. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product event summary: the data files and sheath, 4fc12 with lot number 74757 were returned and analyzed. The data files did not show any issues. Visual inspection of sheath showed the device was intact with no apparent issues. Flushing/air aspiration testing did not show any air passing through the tube or expelled from the distal tip. Functional testing of the sheath confirmed the hemostatic valve was leaking. Air bubbles were observed through the valve. The valve disk was suspected to be torn. In conclusion, the reported air ingress was confirmed through testing. The sheath failed the returned product inspection due to the leaking hemostatic valve. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameFLEXCATH ADVANCE STEERABLE SHEATH
Type of DeviceCATHETER, STEERABLE
Manufacturer (Section D)
MEDTRONIC CRYOCATH LP
9000 autoroute transcanadienne
pointe-claire,qc H9R 5 Z8
CA H9R 5Z8
Manufacturer (Section G)
MEDTRONIC CRYOCATH LP
9000 autoroute transcanadienne
pointe-claire,qc H9R 5 Z8
CA H9R 5Z8
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7663871
MDR Text Key113292773
Report Number3002648230-2018-00462
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
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 09/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/13/2020
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number74757
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/14/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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