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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 05/08/2017
Event Type  malfunction  
Manufacturer Narrative
Product event summary: the data files for the date of the reported event and sheath, 4fc12 with lot 87257, were returned and analyzed. Bin files showed at least nine applications were performed with the balloon catheter, 2af284 with lot 73675, without any issues or system notices on the date of the event. The reported issue, hemostatic valve issue, can not be confirmed through data analysis. Visual inspection of the sheath showed the device was intact with no apparent issues. Air aspiration was reproduced when a test balloon catheter was introduced through the sheath. Dissection showed the hemostatic valve was leaking and that the valve was torn. In conclusion, the reported hemostatic valve leak has been confirmed through testing. The sheath, 4fc12 with lot 87257, 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.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a cryo ablation procedure, the balloon catheter was inserted into the sheath. When air aspiration was performed, air would ¿continuously leak¿ from the hemostatic valve of the sheath. The sheath was replaced with resolve. The case was completed with cryo. No patient complications have been reported as a result of this event.
 
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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 Key6597674
MDR Text Key105647089
Report Number3002648230-2017-00249
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 06/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/10/2019
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number87257
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/10/2017
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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