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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 Problem Vascular System (Circulation), Impaired (2572)
Event Date 01/27/2016
Event Type  Injury  
Manufacturer Narrative
Medtronic cryocath was made aware of this event through a search of literature publications. It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events. This information is based entirely on journal literature. All information provided is included in this report. Patient information is limited due to confidentiality concerns. Since no device id was provided, it is unknown if this event has been previously reported. Referenced article: outcomes after cryoablation vs. Radiofrequency in patients with paroxysmal atrial fibrillation: impact of pulmonary veins anatomy. Europace. 2016.
 
Event Description
The literature publication reported the following patient complications during a cryo ablation procedure: multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers. There was one (1) patient that experienced a tamponade, one (1) patient experienced a thromboembolic event, seven (7) patients had phrenic nerve injury with recovery, seven (7) patients had vascular bleeds, one (1) patient had gastroparesis, one (1) patient had an esophageal ulcer and two (2) patients had hemoptysis. The status/location of the devices were unknown. 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
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key6707787
MDR Text Key79889389
Report Number3002648230-2017-00352
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 08/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2017
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 Received08/24/2016
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: 07/12/2017 Patient Sequence Number: 1
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