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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/Air Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/02/2020
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 cryo ablation procedure, the sheath was aspirated and air was repeatedly aspirated over an unusually long time.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 sheath 4fc12 with lot number 0009961479 was returned and analyzed.Visual inspection showed the device was intact with no apparent issue.Pressure testing did not show any air passing through the tube or expelled from the distal tip.Functional testing showed air bubbles moving through the tube.By pressurizing the sheath, air bubbles came out of the hemostasis valve.In conclusion, the reported air ingress was confirmed through testing.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.
 
Event Description
It was reported that during a cryo ablation procedure, the sheath was aspirated and air was repeatedly aspirated over an unusually long time.The sheath was replaced with resolve.The case was completed with cryo.No patient complications have been reported as a result of this event.
 
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Brand Name
FLEXCATH ADVANCE STEERABLE SHEATH
Type of Device
CATHETER, STEERABLE
Manufacturer (Section D)
MEDTRONIC CRYOCATH LP
9000 autoroute transcanadienne
pointe-claire,qc H9R 5 Z8
CA  H9R 5Z8
MDR Report Key9632219
MDR Text Key195559860
Report Number3002648230-2020-00049
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/17/2021
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number0009961479
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2020
Initial Date Manufacturer Received 01/02/2020
Initial Date FDA Received01/27/2020
Supplement Dates Manufacturer Received02/04/2020
Supplement Dates FDA Received02/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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