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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 10/22/2021
Event Type  malfunction  
Manufacturer Narrative
Product event summary: the 4fc12 sheath with lot 0010566287 was returned and analyzed. Visual inspection prior to disassembly and functional testing was performed on the shaft, handle, and dilator. The inspection identified a shaft kink/twist at 2. 8 approximately inches from the tip. The steering mechanism and deflection test revealed a noise heard from the handle when the knob was turned with friction. Dissection of the returned device revealed a kinked pull wire in the barrel of handle area. In conclusion, the sheath failed the returned product inspection due to a shaft kink. If information is provided in the future, a supplemental report will be issued.
 
Event Description
After a completed case, 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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key13194963
MDR Text Key288694018
Report Number3002648230-2022-00008
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 01/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number0010566287
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2021
Date Manufacturer Received12/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/17/2021
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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