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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 10/06/2016
Event Type  malfunction  
Event Description
It was reported that during a cryoablation procedure, air was continuously noted from the sheath after the balloon catheter was inserted into the sheath. The valve was suspected to have an issue. 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 analysis: data files were returned and analyzed. The data files did not record any system notices on the date of the event. In conclusion, the reported air ingress and hemostatic valve issue could not be confirmed through data analysis. Pending results of the analysis on the returned product. 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.
 
Manufacturer Narrative
Product event summary: the sheath, 4fc12 with lot number 26889, was returned and visual inspection 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 leaking. In conclusion, the reported issue was confirmed through testing. The sheath failed the return product inspection due to a leaking hemostatic valve.
 
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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 Key6072420
MDR Text Key58936831
Report Number3002648230-2016-00469
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,Followup
Report Date 12/12/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/07/2018
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number26889
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/07/2016
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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