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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 Pneumothorax (2012)
Event Date 01/01/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Concomitant medical products: achieve mapping catheter. This information is based entirely on journal literature. The event occurred outside the us. All information provided is included in this report. Patient information is limited due to confidentiality concerns. Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device serial numbers. The baseline gender/age characteristic is male/(b)(6) for the patients referenced in the article. 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: ¿prevalence and pre-procedural predictors associated with right phrenic nerve injury in electromyography-guided, second-generation cryoballoon ablation: single large balloon and single 3-minute freeze techniques. ¿ jacc clin electrophysiol. 2016;2(4):508-514.
 
Event Description
The literature publication reports the following patient complication while using a sheath catheter: there was one (1) patient with pneumothorax during the puncture of the right subclavian vein. 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
16771 chemin ste-marie
kirkland H9H 5 H3
CA H9H 5H3
Manufacturer (Section G)
MEDTRONIC CRYOCATH LP
16771 chemin ste-marie
kirkland H9H 5 H3
CA H9H 5H3
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key6169204
MDR Text Key105635570
Report Number3002648230-2016-00521
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,Followup
Report Date 11/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2016
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 Received11/15/2016
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: 12/13/2016 Patient Sequence Number: 1
Treatment
ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
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