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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 01/24/2017
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 a cryoablation procedure, air was leaking. The balloon catheter was re-inserted without resolve. Then the sheath was replaced and the procedure continued. After the sheath was replaced, micro bubbles were observed inside the side port. Aspiration was performed several times, but the microbubbles were still observed. The sheath was replaced again and the procedure was continued. The case was completed with cryo. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Data files were returned and analyzed. Data files showed did not confirm any issues with the sheath. In conclusion, the reported issue could not be confirmed through data files. Device investigation still in progress. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product event summary: the device were returned and analyzed. Visual inspection of the sheath showed that the device was intact with no apparent issues. Air aspiration was reproduced when a test balloon catheter was introduced through the sheath. A dissection showed that the hemostatic valve was leaking on the sheath. In conclusion, air ingress was confirmed through testing. The sheath failed the returned product inspection due to a leaking hemostatic valve.
 
Manufacturer Narrative
Correction.
 
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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 Key6336848
MDR Text Key105637988
Report Number3002648230-2017-00077
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2017
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 Number85573
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/01/2017
Was Device Evaluated by Manufacturer? No
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: 02/16/2017 Patient Sequence Number: 1
Treatment
4FC12 SHEATH
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