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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); Cardiopulmonary Arrest (1765); Paralysis (1997); ST Segment Elevation (2059); Visual Disturbances (2140)
Event Date 01/31/2018
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 a competitor mapping catheter was inserted into a competitor sheath and positioned in the left atria, st elevation occurred, and the patient's heart beat stopped. It was noted that air ingress in the left ventricle and left atrial appendage was observed via fluoroscopy. When right coronary artery angiography was performed, air ingress in the right coronary artery (rca) was also observed. It was noted that when air ingress occurred, the manufacturer¿s sheath was positioned in the right atrium. A thrombus suction catheter was then used to aspirate air from the rca, with an attempt to aspirate air in the left ventricle and left atrial appendage also performed. It was also reported that the patient was unable to flex the left lower and upper limbs. Medications were administered. The patient regained consciousness, and the patient's pulse recovered. Upon physical examination, the patient's paralysis recovered, however, a visual field defect in the left eye was observed. Angiography and magnetic resonance imaging (mri) were subsequently performed. The case was aborted, and the patient was not under general anesthesia. The patient's hospitalization was extended. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: data files were returned and analyzed. Data files showed that at least 1 application was performed with the balloon catheter on the date of the event with no issues. The device was not returned for investigation/ analysis. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was later reported that the patient's paralysis recovered.
 
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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 Key7297244
MDR Text Key100961665
Report Number3002648230-2018-00114
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 03/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/10/2019
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number64406
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 Received03/05/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/13/2017
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: 02/26/2018 Patient Sequence Number: 1
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