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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 Problem Air Leak (1008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/20/2018
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, air bubble was observed in the sheath irrigation tube. The air was removed via syringe aspiration and the case was completed with cryo. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the device was returned and analyzed. Visual inspection of the sheath showed that the stopcock was intact with no apparent issues. The middle of the sheath was kinked. Air aspiration was re- produced during pressure testing when the test dilator was introduced through the sheath. The hemostatic valve was leaking, and a torn valve was suspected. In conclusion, the reported air ingress issue was confirmed through testing. The device failed the return product inspection test due to a leaking hemostatic valve and shaft kink. 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 Key7663956
MDR Text Key113292947
Report Number3002648230-2018-00466
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeFR
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
Report Date 08/15/2018
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 Date04/16/2020
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number74748
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/18/2018
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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