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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 Cardiac Arrest (1762)
Event Date 12/29/2016
Event Type  Injury  
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, while the sheath and competitor mapping catheter were placed in the heart, the patient experienced pulseless electrical activity/cardiac arrest. The physician performed chest compression until the patient's vital signs recovered. The competitor catheter and sheath were removed. It was noted that air was aspirated from the sheath side port. The procedure was aborted while the patient was under general anesthesia. Additional information received indicated that the patient recovered without issue. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the sheath, 4fc12 with lot 13791, was returned and analyzed. 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 torn and leaking. The patient experienced cardiac arrest. The case was aborted. The patient was recovered without any issue. In conclusion, the reported air aspiration from the sheath was confirmed through testing. The sheath, 4fc12 with lot 13791, failed the returned product inspection due to a leaking hemostatic valve. A clinical issue was experienced during the case.
 
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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 Key6271329
MDR Text Key105637132
Report Number3002648230-2017-00040
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
Report Date 03/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/24/2018
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number13791
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2016
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: 01/23/2017 Patient Sequence Number: 1
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