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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 Fluid/Blood Leak (1250); Kinked (1339)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/01/2017
Event Type  malfunction  
Manufacturer Narrative
Event summary: the patient data files showed at least four injections were performed with catheter 2af284 / 17118-53 on the date of the event without any triggered system notice, data files also showed at least another seven injections were performed with catheter 2af284 / 99242-49 on the date of the event without triggered any system notice.The failure file showed the following system notices have been triggered on the date of the event: #50011 ¿the refrigerant delivery path is obstructed¿; #50012 ¿the refrigerant delivery path is obstructed¿; #50034 ¿the safety system has detected a compromised outer vacuum¿; #50007 ¿the safety system has detected fluid in the console.The system is inoperable¿; #50008 ¿the system has detected a software error and stopped the injection;¿ #50009 ¿the system has detected a failure¿; #50013 ¿the refrigerant level is too low to continue¿; #50014 ¿the balloon is not sufficiently inflated; balloon inflation pressure was not reached in time¿; #50017 ¿the operational temperature of the system is high preventing proper operation¿.#50035 ¿the balloon is deflated¿; #12222 ¿the system detected a refrigerant leak during balloon inflation¿.Upon visual inspection of flexcath sheath 4fc12 / 92497-088, results showed the shaft was kinked 60 mm from the tip.Air aspiration was reproduced when a lab test catheter was introduced through the sheath.Dissection showed the hemostatic valve was leaking.In conclusion, the reported air ingress issue was confirmed through testing but not confirmed through the data analysis.The sheath failed the returned product inspection due to a kink at shaft and a leaking hemostatic valve.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, after the balloon catheter was inserted into the sheath, air was continuously introduced during aspiration.The issue persisted when air aspiration was performed again.The sheath was replaced without resolve.The balloon catheter was replaced with resolve.The physician suspected that the balloon catheter was larger than normal.The case was completed with cryo.No patient complications have been reported as a result of this event.
 
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Brand Name
FLEXCATH ADVANCE STEERABLE SHEATH
Type of Device
CATHETER, 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 Key6825477
MDR Text Key86293727
Report Number3002648230-2017-00467
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 Physician
Type of Report Initial
Report Date 08/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/05/2019
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number92497
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/01/2017
Initial Date FDA Received08/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/05/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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