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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 Arrhythmia (1721); Embolism (1829); Paralysis (1997); Loss of consciousness (2418)
Event Date 03/26/2019
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, the patient lost consciousness after the transeptal puncture. Air was then found in the right coronary vessel. It was noted that the air entered through the sheath. The patient then received two shocks due to ventricular fibrillation. Once the patient's sinus rhythm returned, the patient went into a coma. The case was aborted. Two days later, the patient underwent a cerebral decortication. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was further reported that the patient has now recovered from coma but is hemiplegic and hospitalized for rehabilitation.
 
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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 Key8536255
MDR Text Key142641347
Report Number3002648230-2019-00292
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeIT
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 06/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/24/2021
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number32554
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 Received05/20/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/25/2019
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: 04/22/2019 Patient Sequence Number: 1
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