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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 06/14/2018
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, upon aspiration, air bubbles were aspirated via the hemostatic valve of the sheath. The balloon catheter was advanced and retracted slightly in an attempt to reseat the valve without resolve. The sheath was replaced without resolve. The physician opted to place the valve hub of the sheath under water, and no air bubbles were noted. The case proceeded 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 data files and flexcath sheath, 4fc12 with lot number 07992 were returned and analyzed. The data files showed at least 25 applications were performed with a balloon catheter on the date of the event and system notice 50001 ¿the vacuum is disable due to a problem with the coax cable¿ was triggered on one application. Visual inspection of the 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 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.
 
Manufacturer Narrative
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 Key7654931
MDR Text Key112887626
Report Number3002648230-2018-00453
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/09/2019
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number07992
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/09/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/02/2018 Patient Sequence Number: 1
Treatment
4FC12 SHEATH
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