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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 04/03/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product event summary: the sheath 4fc12 with lot number 63615 was returned and analyzed.Visual inspection of the sheath indicated a shaft kink 2.3 inches from the tip of the shaft.In conclusion, the sheath failed the return product inspection due to the shaft kink.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
After a completed case, the sheath subsequently tested out of spec per the manufacturer¿s investigation.
 
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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 Key8703694
Report Number3002648230-2019-00436
Device Sequence Number1821770
Product Code DRA
UDI-Device Identifier00763000043773
UDI-Public00763000043773
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K123591
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/17/2019
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 Date02/06/2021
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number63615
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/01/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/16/2019
Initial Report FDA Received Date06/17/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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