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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); Paralysis (1997); Brain Injury (2219)
Event Date 02/03/2017
Event Type  malfunction  
Manufacturer Narrative
Product event summary: the data files were returned and analyzed.The data files showed that multiple injections were performed with test catheters without any issue.The sheath was not returned for investigation.A known clinical issue was encountered during the procedure (hemiparesis with a possibility of air ingress).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 post cryoablation procedure, it was difficult to awake the patient.It was noted that the patient had right hemiparesis with a possibility of air ingress during the procedure.The patient¿s hospitalization was extended.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.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received indicated that the air ingress that had occurred led to an air embolism in the patient, which subsequently resulted in irreversible brain damage.
 
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Brand Name
FLEXCATH ADVANCE STEERABLE SHEATH
Type of Device
CATHETER, 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 Key6486124
MDR Text Key72561302
Report Number3002648230-2017-00165
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 02/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/24/2017
Initial Date FDA Received04/12/2017
Supplement Dates Manufacturer Received03/24/2017
01/17/2019
Supplement Dates FDA Received10/02/2017
02/13/2019
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 Sequence Number1
Patient Outcome(s) Hospitalization;
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