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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 01/13/2017
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 cryoablation procedure, the balloon catheter was removed from the sheath, and a competitor catheter was inserted. Air was ¿purged¿ and it was noted that an unusually large amount of air was drawn. The issue persisted when the sheath and the catheter were connected coaxially. All the air seemed to be drawn out after three cycles; therefore, not device was replaced. The case was completed with cryo. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: clinical data files were received and reviewed. The files show at least 4 injections with the balloon catheter without issue on the date of the event. Data analysis cannot confirm issues with the sheath, which was not returned for investigation and therefore unable to be analyzed.
 
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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 Key6297202
MDR Text Key105637984
Report Number3002648230-2017-00064
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 01/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2018
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number31056
Was Device Available for Evaluation? No
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 Manufactured09/29/2016
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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