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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 Fistula (1862); Pseudoaneurysm (2605); Pericardial Effusion (3271)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
This information is based entirely on journal literature. Medtronic was made aware of this event through a search of literature publications. This event occurred outside the us. Patient information is limited due to confidentiality concerns. Of note, multiple patients and multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers. The baseline gender/age characteristics is male/(b)(6) years old. 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: efficacy of cryoablation in idiopathic and non-idiopathic atrial fibrillation patients. 2021. 122 (2). 89¿94. Doi: 10. 4149/bll_2021_013. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A journal article was reviewed that contained information regarding cryoablation in idiopathic and non-idiopathic atrial fibrillation (af) patients. The article reports patients that had pericardial effusion which required pericardiocentesis, groin complications, such as arteriovenous fistulas and pseudoaneurysms, which were treated surgically. The status/disposition of the catheters and sheaths is unknown. No further patient complications have been reported as a result of this event. Further follow up did not yet yield any additional information.
 
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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 Key11636098
MDR Text Key245099965
Report Number3002648230-2021-00166
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeLO
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4FC12
Device Catalogue Number4FC12
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 Received03/18/2021
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: 04/08/2021 Patient Sequence Number: 1
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