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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE

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MEDTRONIC, INC. FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE Back to Search Results
Model Number 4FC12
Device Problem Gas Leak (2946)
Patient Problem Air Embolism (1697)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
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. 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. Multiple patients were described with the following age/gender: age (b)(6) years (male). Age (b)(6) years (female). A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Clinically manifesting air embolisms in cryoballoon ablation jacc: clinical electrophysiology 2020; 6(9):1067¿72. Https://doi. Org/10. 1016/j. Jacep. 2020. 07. 012. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A journal article was reviewed that contained information regarding sheaths during cryoablation procedures. The authors discussed cases of air embolisms and the usefulness of utilizing water buckets to prevent air from being introduced while inserting the catheter into the transseptal sheath. There were nine patients who developed coronary air embolisms and in two patients multiple air bubbles were identified and those patients underwent emergent coronary angiography. All the patients recovered under conservative treatment without any sequela. The disposition of the product is not known. 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 ADVANCE STEERABLE SHEATH
Type of DeviceCATHETER, STEERABLE
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10759838
MDR Text Key213843579
Report Number2182208-2020-02593
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
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 10/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received10/07/2020
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: 10/29/2020 Patient Sequence Number: 1
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