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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
Medical Device Problem Code Material Twisted/Bent (2981)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/07/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that during a cryo ablation procedure, the sheath was unable to cross the septum.The sheath was removed and displayed a kink between the tip and the dilator.The sheath was replaced.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
Common Device Name
CATHETER, STEERABLE
Manufacturer (Section D)
MEDTRONIC CRYOCATH LP
9000 autoroute transcanadienne
pointe-claire,qc H9R 5 Z8
CA  H9R 5Z8
MDR Report Key8770870
Report Number3002648230-2019-00484
Device Sequence Number11262354
Product Code DRA
UDI-Device Identifier00763000043773
UDI-Public00763000043773
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
PMA/510(K) Number
K123591
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/09/2019
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
Operator of Device Health Professional
Device Expiration Date03/19/2021
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number39807
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/13/2019
Initial Report FDA Received Date07/09/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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