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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); Low Blood Pressure/ Hypotension (1914); Paralysis (1997); ST Segment Elevation (2059)
Event Date 04/19/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was later reported the patient¿s pre-existing condition of sleep apnea syndrome in combination with insufficient sedation may have contributed to air entering the sheath.
 
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, while the competitor mapping catheter was inserted into the sheath, blood pressure dropped and st elevation was observed. An angiogram confirmed the presence of air in the right coronary artery. Air aspiration was attempted but the patient had a spasm. The patient was then transferred to another hospital, where magnetic resonance imaging (mri) scans of the head were negative for air. The patient regained consciousness and is able to speak, but has palsy and paralysis in four limbs. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the data files were returned and analyzed. The data files confirmed system notice 50012 ¿the refrigerant path is obstructed¿ unrelated to the clinical issue. The data files also showed multiple injections were performed. The sheath was not returned for investigation. A known clinical issue was encountered during the procedure (air embolism, hypotension and st elevation). If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was further reported that the patient was transferred to the department of neurosurgery in another hospital and the patient still had aftereffects such as paralysis.
 
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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 Key6570538
MDR Text Key105644316
Report Number3002648230-2017-00229
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,Followup,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot NumberUNKNOWN
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 Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
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: 05/16/2017 Patient Sequence Number: 1
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