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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 Gas Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/01/2020
Event Type  malfunction  
Manufacturer Narrative
Product event summary: the sheath 4fc12 with lot number 0010034020 was returned and analyzed. Visual inspection showed the sheath was intact with no apparent issues. The sheath's distal tip was intact; no fractures, breaks or kinks noticed. No teflon delamination noticed at the tip of the shaft. Functional testing showed that deflection worked per specification. The returned sheath passed the pressure test with the sentinel black leak tester machine. Flushing/aspiration test did not show any air passing through the tube or expelled from the sheath distal tip. In conclusion, the reported air ingress was not confirmed through testing. The sheath did not fail the returned product inspection due to the air ingress. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a cryo ablation procedure, air ingress occurred when the balloon catheter was inserted into the sheath. The case was completed with cryo. No 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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key9988280
MDR Text Key195761628
Report Number3002648230-2020-00232
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
Report Date 04/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/02/2021
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number0010034020
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/03/2019
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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