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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 05/01/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Event summary: the patient data files showed fourteen injections were performed with catheter 2af284/59616-28 without any issues or system notices. Upon visual inspection of flexcath sheath 4fc12/47540-042, results showed the device was intact with no apparent issues. Functional testing of the sheath confirmed the hemostatic valve was leaking. Air bubbles were observed through the valve. It was suspected that the valve disk was torn. This is a case related to a clinical issue (right bundle branch block) and air ingress. In conclusion, the reported air ingress issue has been confirmed through testing. The reported right bundle branch block cannot be confirmed through data analysis. This is a clinical issue. The sheath failed the returned product inspection due to a leaking hemostatic valve. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
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.
 
Event Description
It was reported that during a cryo ablation procedure, it was observed that the sheath was reinserted into the left atrial side and air was being aspirated from the sheath port. It was also indicated that the dilator lock ¿felt weaker than usual. ¿ the sheath was replaced with resolve. The case was completed with cryo. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the data files were returned and analyzed. The data files did not show system notices or issues for the date of the event. There was no indication of a product malfunction, and the sheath was returned for investigation. If information is provided in the future, a supplemental report will be issued.
 
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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 Key6590244
MDR Text Key105646987
Report Number3002648230-2017-00244
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
Report Date 12/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/26/2019
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number47540
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/01/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/27/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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