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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 Gas Leak (2946)
Patient Problems Embolism (1829); Low Blood Pressure/ Hypotension (1914); Paralysis (1997); ST Segment Elevation (2059); Ventricular Tachycardia (2132)
Event Date 07/07/2020
Event Type  Injury  
Manufacturer Narrative
Product event summary: the 4fc12 sheath with lot 0010130780 was returned and analyzed. Visual inspection showed the shaft was intact with no apparent issues. Multiple aspirations and injections were performed without air bubbles or leaks, and the hemostatic valve was leak tight. The reported air ingress issue could not be reproduced. The clinical issues (st elevation, ventricular tachycardia, hypotension, transient paralysis of the left side of the body, and air embolism) occurred during the case. In conclusion, the reported air ingress issue was not confirmed through testing. There is no indication of a relation of the adverse events to the performance and malfunction of the product. The sheath passed the returned product inspection as per specification. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a cryo ablation procedure, transeptal access was lost and the sheath was exchanged. St elevation, ventricular tachycardia, and hypotension were all observed. A cardioversion was performed and pressure was supported with anesthesia. Slowly the st elevation went down. The case was aborted. Upon awaking from the procedure, the patient displayed a transient paralysis of the left side of their body which later recovered. A computed tomography scan of the brain was performed. An air embolism, indicating air ingress occurred at one point, was suspected. The patient's hospitalization was extended. No further patient complications have been reported as a result of this event.
 
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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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10328497
MDR Text Key200601643
Report Number3002648230-2020-00377
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeCA
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
Report Date 07/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/25/2022
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number0010130780
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/26/2020
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: 07/27/2020 Patient Sequence Number: 1
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