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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 Gas Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Air Embolism (1697); ST Segment Elevation (2059); Cardiogenic Shock (2262)
Event Date 12/26/2018
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, when the balloon catheter was inserted into the sheath and then inserted into the left atrium, st elevation occurred. Back-up pacing was performed to resolve the st elevation. Additionally, air ingress was observed in the aorta. A thrombosis aspiration catheter was used to aspirate the air in the aorta. A coronary angiography was subsequently performed and an air embolism was observed in the right coronary artery, which was also aspirated with resolve. Air was observed in the left auricle, and ¿pig tail¿ was used to aspirate the air. The case was then aborted while the patient was not under general anesthesia. It was also reported that the patient also experienced cardiogenic shock. It was further reported the physician believes there is a high possibility that when the sheath was inserted into the left atrium and dilator removed, air ingress occurred. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Event summary: visual inspection of sheath 4fc12/ 85233- 082 showed the device was intact with no apparent issues. Several flushes and aspirations were performed without issues while the balloon catheter was inserted. Aspiration/flushing test did not show any air passing through the tube or expelled from the sheath distal tip. Multiple aspirations / injections were performed without air bubbles or leaks through the hemostatic valve when a test balloon catheter was introduced through the sheath. Hemostatic valve was leak tight. There is no sufficient evidence that the devices potentially caused these adverse events. In conclusion, this is a clinical issue (st elevation, air embolism) were encountered during the procedure. The reported air ingress issue was not confirmed through the testing for the returned sheath. The sheath passed the product inspection as per specification. There is no indication of relation of adverse event to the performance of the sheath. 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 Key8261615
MDR Text Key133559335
Report Number3002648230-2019-00040
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
Report Date 02/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2020
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number85233
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/26/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/29/2018
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: 01/18/2019 Patient Sequence Number: 1
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