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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); Hematoma (1884); Pseudoaneurysm (2605)
Event Date 09/16/2020
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 characteristics is male/56 years old. Of note, multiple patients/multiple manufacturers/multiple methods were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers/manufacturer/method. 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:"intra-procedural three-dimensional rotational angiography in cryoballoon ablation for atrial fibrillation" the international journal of cardiovascular imaging. 2020. Doi. Org/10. 1007/s10554-020-02029-7. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The literature publication reported the following patient complications during a cryoablation procedure: one (1) patient experienced phrenic nerve palsy (pnp) that eventually recovered by the six month follow up, as confirmed by normal chest x-ray. One (1) patient developed an arterial pseudoaneurysm which extended the patient's hospitalization and was treated by prolonged groin compression under ultrasound guidance. One (1) patient developed an arterio-venous fistula that required surgical closure and prolonged hospitalization. Five (5) patients developed groin hematomas. Each patient with a large hematoma underwent groin ultrasound examination to exclude major vascular complications. 11 patients experienced transient phrenic nerve palsy (pnp) that fully recovered by the end of the procedure. The status of the catheters is unknown. Follow up is being conducted for additional information on the catheters. 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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key11107966
MDR Text Key224759229
Report Number3002648230-2021-00001
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeHR
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 01/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot NumberUNKONWN
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 Received12/14/2020
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: 01/04/2021 Patient Sequence Number: 1
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