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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 Gas Leak (2946)
Patient Problems Embolism (1829); Vascular System (Circulation), Impaired (2572)
Event Date 01/01/2019
Event Type  malfunction  
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. 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/age characteristics is male/64 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: ¿mid-term outcomes of concomitant left atrial appendage closure and catheter ablation for non-valvular atrial fibrillation: a multicenter registry. ¿ heart and vessels. 2019; 34(5):860-867. Doi:// 10. 1007/s00380-018-1312-4. 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 was one (1) patient who experienced a vascular complication; with no indicated treatment/resolution. There was reported ¿air embolism¿ seen during the ablation procedure for one (1) patient. 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 status/disposition of the cryoablation 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 Key8680379
MDR Text Key147382570
Report Number3002648230-2019-00424
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeCH
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 06/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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 Received05/15/2019
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: 06/07/2019 Patient Sequence Number: 1
Treatment
ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
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