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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 Leak (1250); Gas Leak (2946)
Patient Problems Arrhythmia (1721); Cardiac Arrest (1762); Embolism (1829); Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059); Ventricular Fibrillation (2130)
Event Date 10/15/2018
Event Type  Injury  
Manufacturer Narrative
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 dilator of the sheath was removed, st elevation occurred. A coronary angiography was performed and showed that an air embolism had developed. Aspiration was performed with a competitor air suction catheter and intra aortic balloon pump. It was observed with an angiography and fluoroscopy. It was noted that during aspiration, cardiac arrest and ventricular fibrillation (vf) occurred three times and the patient was hypotensive. The patient recovered two hours after leaving the catheter lab. The case was aborted and it was noted that the patient was not under general anesthesia. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the sheath was returned and analyzed. Visual inspection of reported sheath 4fc12 lot number 72813 showed the device was intact with no apparent issues. Flushing and air aspiration testing did not show any air passing through the tube or expelled from the distal tip. However, functional testing of the sheath confirmed the hemostatic valve was leaking. Air bubbles were observed through the valve, and it was suspected that the valve disk is torn. In conclusion, the reported air ingress issue was confirmed through product testing. The clinical issues (cardiac arrest, air embolism, st elevation, hypotension, ventricular fibrillation, and aborted under general anesthesia) that were encountered during the case were not confirmed through product testing. The reported sheath failed the returned product inspection due to a leaking hemostatic valve. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product event summary: the data files were returned and analyzed. The data files showed that at least 25 applications were performed with balloon catheter 2af284 with lot number 22188 on the date of the event. Unrelated system notice #50012 ¿the refrigerant delivery path is obstructed¿ was triggered on first and second ablations. The data files showed at least two more applications were performed with non-returned catheter 238f5 with lot number 95745 without any issue on the date of the event. The reported air ingress issue could not be assessed through data analysis. If information is provided in the future, a supplemental report will be issued.
 
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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
lisa robertson
8200 coral sea st ne
mounds view, MN 55112
7635262723
MDR Report Key8056253
MDR Text Key126705656
Report Number3002648230-2018-00797
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 02/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number72813
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2019
Was Device Evaluated by Manufacturer? Yes
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: 11/09/2018 Patient Sequence Number: 1
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