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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 Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Pericardial Effusion (3271)
Date of Event 03/19/2018
Type of Reportable Event Serious Injury
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 cryoablation procedure, a pericardial effusion occurred.A pericardial window was then performed.The case was completed with cryo.The patient had an extended hospitalization, and remains in the hospital.No further patient complications have been reported as a result of this event.It was noted that the patient was feeling delightful the following day.
 
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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 Key7409482
Report Number3002648230-2018-00206
Device Sequence Number1252093
Product Code DRA
UDI-Device Identifier00643169688872
UDI-Public00643169688872
Combination Product (Y/N)N
Initial Reporter StateTN
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) 04/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date12/21/2019
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number25940
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/19/2018
Initial Report FDA Received Date04/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
2AF284 BALLOON CATHETER, 2ACH20 MAPPING CATHETER
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age86 YR
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