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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 Fluid Leak (1250); Gas Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/15/2018
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, during aspiration, air was aspirated through the sheath valve. The sheath was replaced with resolve. The case was completed with cryo. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the sheath was returned and analyzed. Visual inspection of the reported sheath 4fc12 33736 showed the device was intact with no apparent issues. Air aspiration was reproduced during the pressure test when the test dilator was introduced through the sheath. Additionally, the hemostatic valve was leaking, and it was suspected that the valve disk was torn. In conclusion, the reported air ingress issue was confirmed through product analysis. The reported sheath failed the returned product inspection due to a 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
MDR Report Key8120762
MDR Text Key128922266
Report Number3002648230-2018-00896
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/27/2020
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number33736
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2019
Is This a Reprocessed and Reused Single-Use Device? No

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