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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 Device Operates Differently Than Expected (2913)
Patient Problems Nerve Damage (1979); Pneumothorax (2012)
Event Date 01/01/2016
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 61 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: early recurrence after pulmonary vein isolation of paroxysmal atrial fibrillation with different ablation technologies: prospective comparison of radiofrequency vs. Second-generation cryoballoon ablation. Circ. J. 2016;80(2):346-353. (b)(4).
 
Event Description
Miyazaki smd, kuroi a, hachiya h, et al. Early recurrence after pulmonary vein isolation of paroxysmal atrial fibrillation with diff erent ablation technologies: prospective comparison of radiofrequency vs. Second-generation cryoballoon ablation. Circ. J. 2016;80(2):346-353. The literature publication reported the following patient complications" one patient experienced phrenic nerve injury (pni) and a pneumothorax. 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
16771 chemin ste-marie
kirkland,qc 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 Key5447904
MDR Text Key38582793
Report Number3002648230-2016-00052
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 02/08/2016
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
Treatment
ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
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