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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 Appropriate Term/Code Not Available (3191)
Patient Problem Vascular System (Circulation), Impaired (2572)
Event Date 01/01/2017
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: achieve mapping catheter. Medtronic was made aware of this event through a search of literature publications. It was not possible to ascertain specific patient or device information from the literature publication or to match the event with previously reported events. This information is based entirely on journal literature. All information provided is included in this report. Patient information is limited due to confidentiality concerns. The model listed in the report is a representative of the model family, as there is no specific model listed. Multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers. The baseline gender/age of the patients represented in the article is male/(b)(6) years old. Without a lot number or device serial number, the manufacturing date cannot be determined. Referenced article: single freeze strategy with the second- generation cryoballoon for atrial fibrillation: a multicenter international retrospective analysis in a large cohort of patients. Journal of interventional cardiac electrophysiology. 2017; 49(2):173-180. 10. 1007/s10840-017-0254-6. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The literature publication reports the following patient complication while using a sheath catheter: there were ten patients who had vascular access complications; some of which required surgery and prolonged hospitalization. The status/location of the sheath catheter is unknown. 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
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7004302
MDR Text Key91131228
Report Number3002648230-2017-00593
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeBE
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 11/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2017
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 Received11/02/2017
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: 11/06/2017 Patient Sequence Number: 1
Treatment
ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
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