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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 Problem Fistula (1862)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical product: arctic front advance cardiac cryoablation catheter 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 u. S. All information provided is included in this report. Patient information is limited due to confidentiality concerns. Multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers. The gender of the baseline characteristics is male and the baseline age is 64 years old. The baseline weight is 64 kgs. 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: ¿multicenter study of the validity of additional freeze cycles for cryoballoon ablation in patients with paroxysmal atrial fibrillation. ¿ circulation. Arrhythmia and electrophysiology. 2019; 12(1):e006989. 10. 1161/circep. 118. 006989. 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 system: there were two (2) patients with pericardial tamponade/effusions: one (1) in which required drainage and one patient in which it did not. There were two (2) patients who had transient st elevation ¿presumably because of an air embolism occurred,¿ both of which resolved within ¿seconds. ¿ there were eight (8) patients with transient phrenic nerve palsy (pnp), all of which resolved by ten months post-procedure. One (1) patient had ¿severe¿ pulmonary vein stenosis; with unknown treatment/resolution. Three (3) patients had hematomas or pseudoaneurysms at the puncture site; with unknown treatment/resolution. There were two (2) patients who had an arteriovenous fistula; with no treatment/resolution indicated. There was one patient who had gastric hypo-motility. The status/location of the ablation system is unknown. According to the article, "no cerebral infarctions, transient ischemic attacks, atrioesophageal fistulae, or procedure-related deaths occurred in any patient. " 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 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
lisa robertson
8200 coral sea st ne
mounds view, MN 55112
7635262723
MDR Report Key8348561
MDR Text Key136502162
Report Number3002648230-2019-00118
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 02/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2019
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 Received01/22/2019
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: 02/18/2019 Patient Sequence Number: 1
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