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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 Air Leak (1008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/21/2016
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during to a cryo ablation procedure, the balloon catheter was difficult to insert into the sheath and air was observed over the side port. The balloon catheter and sheath were replaced with resolve. The case was completed with cryo. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Event summary: the patient data files cannot show the reported issue (air ingress in the system) on the event date. At least nine ap plications were performed with catheter 2af283/1871-36 on the date of the event with no detected issue. Upon visual inspection of 4fc12 / 85598-051, results showed the sheath shaft was intact with no apparent issues. Air aspiration was reproduced when a catheter was introduced through the sheath. Dissection results showed the hemostatic valve was leaking; and the valve was torn. In conclusion, the reported air aspiration was reproduced during testing. The sheath failed the returned product inspection due to a leaking hemostatic valve. The reported insertion issue has not been confirmed through testing. The catheter was not returned.
 
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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 Key6273953
MDR Text Key105637987
Report Number3002648230-2017-00045
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/01/2018
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number85598
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2016
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: 01/24/2017 Patient Sequence Number: 1
Treatment
2AF283 CATHETER
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