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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); Unspecified Infection (1930); 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. All information provided is included in this report. Patient information is limited due to confidentiality concerns. Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers. The overall baseline gender characteristics is male; the age of the patients was approximately 62 years old. The majority of the patients were white and not of hispanic or latino race. 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. Of note, this article has been written using the following clinical trial: the ambulate (a randomized, multi-center trial to compare cardiva mid-bore vvcs to manual compression in closure of multiple femoral venous access sites in 6 - 12 fr sheath sizes) trial was a randomized, controlled, open-label investigational device exemption clinical trial conducted at multiple u. S. Sites ((b)(6)). A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Referenced article: ¿venous vascular closure system versus manual compression following multiple jacc: clinical electrophysiology. Volume 6, issue 1, january 2020, pages 111-124. Doi//10. 1016/j. Jacep. 2019. 08. 013. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The literature publication reported the following patient complications during the use of a cryoballoon ablation catheter system: there were patients who experienced ¿minor¿ access site complications, hematomas, transient nerve injury; all with no indication of treatment/resolution. One patient had an arteriovenous fistula, which did not require any treatment. There were also patients with infections, and pseudoaneurysms; all with treatment required. Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers. The status/disposition of the cryoablation catheter system 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 Key9647783
MDR Text Key176997977
Report Number3002648230-2020-00057
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 01/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2020
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2020
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: 01/30/2020 Patient Sequence Number: 1
Treatment
ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
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