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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 Problem Air Embolism (1697)
Event Date 01/19/2017
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 during a cryoablation procedure, electrocardiogram showed st elevation after the balloon temperature was rewarmed and the balloon was deflated. Nitroglycerin was given to the patient with resolve. However, fluoroscopy showed air remained in the left atrial appendage. The physician mistakenly still opened one of triple-three-way stopcock connecting to the balloon catheter while balloon occlusion in the left superior pulmonary vein was checked. It was confirmed that was why air ingress occurred. The balloon catheter was removed from the sheath and air was removed again. Air in the left atrial appendage was removed using the sheath. The case was completed with cryo. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Event summary: the patient data files cannot show the reported issue (air ingress in the system, embolism, st elevation) on the event date. At least nine applications were performed with catheter (b)(4) on the date of the event with no detected issue. No products were returned. In conclusion, this is a clinical issue (st elevation) during the case. Products (b)(4) were not returned.
 
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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 Key6329673
MDR Text Key105637391
Report Number3002648230-2017-00070
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 02/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/14/2018
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number29928
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/14/2016
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: 02/14/2017 Patient Sequence Number: 1
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