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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH STEERABLE SHEATH CATHETER, STEERABLE

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MEDTRONIC CRYOCATH LP FLEXCATH STEERABLE SHEATH CATHETER, STEERABLE Back to Search Results
Model Number 3FC12
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fistula (1862); Hematoma (1884); Cardiac Tamponade (2226); Vascular System (Circulation), Impaired (2572); Pseudoaneurysm (2605)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
Medtronic 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. This event occurred outside the us. All information provided is included in this report. Patient information is limited due to confidentiality concerns. The baseline gender/age of the patients represented in the article is male/60 years old. Of note, multiple patients/multiple methods/multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers/methods/manufacturers. The model listed in the report is a representative of the model family, as there is no specific model listed. Without a lot number or device serial number, the manufacturing date cannot be determined. Since no device id was provided, it is unknown if this event has been previously reported. A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly referenced article: ¿updated national multicenter registry on procedural safety of catheter ablation for atrial fibrillation. ¿ journal of cardiovascular electrophysiology. 2013; 24(10):1069-1074. Doi:// 10. 1111/jce. 12194. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The literature publication reports the following patient complications while using a cryoablation balloon/sheath catheter/phased radio frequency ablation catheter: in 94 patients: ¿vascular access complications (28 femoral hematoma, 13 arteriovenous fistula, 7 femoral pseudoaneurysm, and two (2) subclavian hematomas); 12 patients developed cardiac tamponade, successfully drained in all cases; 14 patients presented with pericarditis; five (5) patients had transient ischemic attack; four (4) patients had stroke (three (3) ischemic and one (1) hemorrhagic); three (3) patients had phrenic nerve paralysis during right pulmonary vein (pv) isolation; three (3)patients had hemothorax that required drainage in two (2). Other isolated but serious adverse events were documented in three (3) patients; stenosis >50% in one (1); sinus bradycardia that required transient cardiac stimulation in one (1). ¿ the status/location of the cryoballoon catheter/sheath catheter/phased radio frequency ablation catheter is unknown. Further follow up did not yet yield any additional information. No further patient complications have been reported as a result of this event.
 
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Brand NameFLEXCATH 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 Key9077761
MDR Text Key162998552
Report Number3002648230-2019-00665
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K081049
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 09/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number3FC12
Device Catalogue Number3FC12
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2019
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: 09/17/2019 Patient Sequence Number: 1
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