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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 4FC12
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Unspecified Infection (1930); Pseudoaneurysm (2605)
Event Date 12/01/2015
Event Type  Injury  
Manufacturer Narrative
Medtronic cryocath 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 gender of the baseline characteristics is male and the baseline age is approximately 56 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. Referenced article: point-by-point radiofrequency ablation versus the cryoballoon or a novel combined approach: a randomized trial comparing 3 methods of pulmonary vein isolation for paroxysmal atrial fibrillation (the cryo versus rf trial). Journal of cardiovascular electrophysiology. 2015;26(12):1307-1314. (b)(4).
 
Event Description
Hunter rj, baker v, finlay mc, et al. Point-by-point radiofrequency ablation versus the cryoballoon or a novel combined approach: a randomized trial comparing 3 methods of pulmonary vein isolation for paroxysmal atrial fibrillation (the cryo versus rf trial). Journal of cardiovascular electrophysiology. 2015;26(12):1307-1314. The cryo versus rf trial introduction catheter ablation of paroxysmal af using the cryoballoon (cryo) has yielded similar success rates to conventional wide encirclement using radiofrequency catheter ablation (rfca), but randomized data are lacking. Pilot data suggested a high success rate with a combined approach (combined) using wide encirclement with rfca followed by 2 cryo applications to each vein. We compared these 3 strategies in a randomized controlled trial. Methods and results patients undergoing first time paroxysmal af ablation were randomized to rfca, cryo, or combined. Patients were followed up at 3, 6, and 12 months with 7 days of ambulatory ecg monitoring. Success was defined as freedom from arrhythmia without antiarrhythmic drugs after a single procedure. A total of 237 patients were randomized. Success at 1 year was achieved in 47% in the rfca group, 67% in the cryo group, and 76% in the combined group (p <(><<)> 0. 001 for rfca vs. Cryo, p<(><<)> 0. 001 for rfca vs. Combined, rfca vs. Cryo, and cryo vs. Combined groups). Conclusions pulmonary vein isolation for paroxysmal af is faster with cryo and results in a higher single procedure success rate than conventional point by point rfca. The combined approach was not superior to cryo alone. The literature publication reported the following patient complication: there was one patient who experienced a femoral pseudo-aneurysm which was treated with thrombin infection. 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
16771 chemin ste-marie
kirkland H9H 5 H3
CA H9H 5H3
Manufacturer (Section G)
MEDTRONIC CARDIAC RHYTHM HEART FAILURE
8200 coral sea st ne
mounds view MN 55112
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key5448866
MDR Text Key38637576
Report Number3002648230-2016-00053
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K081049
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 02/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2016
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 Received02/08/2016
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: 02/19/2016 Patient Sequence Number: 1
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