• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 09/05/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: 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 us. All information provided is included in this report. Patient information is limited due to confidentiality concerns. The baseline gender/age/weight for the ¿elderly group¿ characteristics is female/78 years old/79 kg; baseline gender/age/weight for the ¿control group¿ characteristics is male/60 years old/91 kg. Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers. 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: safety and efficacy of cryoballoon ablation for the treatment of atrial fibrillation in elderly patients. ¿ clinical research in cardiology. Https://doi. Org/10. 1007/s00392-018-1336-x. 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 system: there were two (2) patients who experienced pericardial tamponade; with pericardial puncture treatment, but no surgical treatment was required. There were also patients who experienced hematomas, and av fistulas; with unknown treatment/resolution. Extended hospital stays were required for some patients. There were also seven (7) patients who had transient phrenic nerve palsy (pnp); all of which resolved ¿spontaneously¿ during follow up. 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/location 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7931206
MDR Text Key122533236
Report Number3002648230-2018-00713
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
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 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2018
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 Received09/10/2018
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: 10/03/2018 Patient Sequence Number: 1
Treatment
ACHIEVE MAPPING CATHETER
-
-