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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 Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/13/2022
Event Type  malfunction  
Manufacturer Narrative
Product event summary: the 4fc12 sheath with lot number 0010546750 was returned and analyzed. External visual inspection showed that the sheath's shaft had a kink at approximately four inches from the handle. Further inspection was done and the tip was inspected under microscope, it was intact and did not show any deformities. The dilator returned along with the sheath was intact and was able to lock into the returned sheath without any issues. The deflection angle was inspected and it was in specification. The deflection mechanism was inspected and there was no abnormality noticed in it. In conclusion, the sheath failed the returned product inspection due the shaft kink. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The sheath subsequently tested out of specification per the manufacturer's investigation.
 
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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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key13695098
MDR Text Key289462379
Report Number3002648230-2022-00092
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/08/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number0010546750
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2022
Date Manufacturer Received02/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/08/2021
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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