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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 No Known Impact Or Consequence To Patient (2692)
Event Date 11/22/2016
Event Type  malfunction  
Event Description
It was reported that during a cryoablation procedure the account mentioned that air in the line might have been injected into the patient.The case was completed with cryo.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the sheath was not returned.Clinical data files were received and reviewed, confirming a system notice #(b)(4)"outer vacuum compromised" for the date of case.System notice #(b)(4)"outer vacuum compromised" could be related to an intermittent electrical signal from the auto-connection box or electrical umbilical cable.The auto-connection box and the electrical umbilical cable for this case were not returned.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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, quebec H9R 5 Z8
CA  H9R 5Z8
Manufacturer (Section G)
MEDTRONIC CRYOCATH LP
9000 autoroute transcanadienne
pointe-claire, quebec H9R 5 Z8
CA   H9R 5Z8
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key6173990
MDR Text Key62377561
Report Number3002648230-2016-00527
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 11/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/22/2016
Initial Date FDA Received12/14/2016
Supplement Dates Manufacturer ReceivedNot provided
01/03/2017
Supplement Dates FDA Received01/23/2017
09/28/2017
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
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