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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 Aspiration Issue (2883)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/08/2016
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted. (b)(4).
 
Event Description
It was reported that during a cryoablation procedure, the sheath valve exhibited an unusual amount of air on aspiration. The case was able to be completed with cryo. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Product event summary: the flexcath advance sheath, 4fc12 with lot number 03358, and data files were returned and analyzed. The data files did not show any system notices for the date of the reported event. Visual inspection of the sheath showed the shaft was intact with no apparent issues; the reported issue of air ingress could not be reproduced. Multiple aspirations and injections were performed without air bubbles or leaks; the hemostatic valve and valve assembly were leak tight. In conclusion, the reported issue of air ingress was not confirmed through testing. The flexcath advance sheath, 4fc12 with lot number 03358, passed the returned product inspection as per specification.
 
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Brand NameFLEXCATH ADVANCE STEERABLE SHEATH
Type of DeviceCATHETER, STEERABLE
Manufacturer (Section D)
MEDTRONIC CRYOCATH LP
16771 chemin ste-marie
kirkland H9H 5 H3
CA H9H 5H3
Manufacturer (Section G)
MEDTRONIC CARDIAC RHYTHM HEART FAILURE
8200 coral sea st ne
mounds view MN 55112
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key5427815
MDR Text Key104704276
Report Number3002648230-2016-00041
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123591
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,Followup
Report Date 02/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/10/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/09/2017
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number03358
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/10/2015
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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