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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 Problems Air Embolism (1697); Bradycardia (1751); Cardiac Arrest (1762); Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059)
Event Date 02/08/2017
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 when the cryo ablation procedure was complete, the balloon catheter was removed from the sheath and a competitor catheter was then inserted. It was then noted that the patient¿s heart rate and blood pressure dropped and st segments were verified to have gone up. Additionally, ¿temporary cardiac arrest was observed¿. Ventricular pacing was performed and the sheath was placed in the right atrium. It was then confirmed that air inclusion occurred and nitroglycerin was administered. Aspiration was then performed and a significant amount of air was aspirated. It was confirmed that the intrinsic rhythm had recovered and the blood pressure was stable. The case was completed with cryo. Following the procedure, mri scans of the head showed micro cerebral infarction, however, it was reported this was an expected symptom resulting from a cryoablation procedure. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the data files and sheath, 4fc12 with lot number 42972 were returned and analyzed. The data files confirmed system notice 50013 ¿the refrigerant level is too low to continue¿ unrelated to the clinical issue. The data files also showed multiple injections were performed. 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. A clinical issue was encountered during the case. In conclusion, the sheath failed the returned product inspection due to 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
Air embolism was confirmed. "when the arctic front advance was removed from the flex cath advance, air inclusion occurred at the timing of insertion of other manufacturer's ring catheter. According to the physician, the cause was considered that the patient might have breathed deeply at the timing when the shaft of the ring catheter had been applying tension to the sheath, and at this time, large amount of air inclusion had been occurred at the gap of the sheath. ".
 
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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 Key6377131
MDR Text Key105638702
Report Number3002648230-2017-00102
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 02/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/17/2018
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number42972
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/17/2016
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: 03/03/2017 Patient Sequence Number: 1
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