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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Inflammation (1932); Nausea (1970); Pain (1994); Vomiting (2144)
Event Date 12/05/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that following a successful cryo ablation procedure, the patient experienced stomach pain, nausea, and vomiting. Medications were administered to the patient to ease discomfort. It was additionally reported that the patient experienced chest pain and pericarditis, as well as mild fluid overload. An exam noted a few pulmonary crackles at bases bilaterally. Medications were administered to treat the chest pain, pericarditis, and fluid overload. The patient is a participant in a clinical study. No further patient complications have been reported as a result of this event.
 
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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 Key9708138
MDR Text Key182956794
Report Number3002648230-2020-00088
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
Type of Report Initial
Report Date 02/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received01/14/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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: 02/13/2020 Patient Sequence Number: 1
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