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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 Problems Device Contamination with Body Fluid (2317); Gas Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817); Paralysis (1997); Speech Disorder (4415)
Event Date 10/28/2021
Event Type  Injury  
Event Description
It was reported that during a cryo ablation procedure, blood was drawn into the sheath via the sideport after inserting it into the patient. The balloon catheter was inserted, but blood continued to enter the sideport of the sheath. The sheath was removed and replaced, in which air ingress occurred. St elevation was then observed. A vasodilator was administered and the st elevation resolved. The case was completed with cryo. Following the procedure, the patient did not wake up from anesthesia. A magnetic resonance imaging (mri) was performed and a cerebral infarction and embolus was confirmed in the left hemisphere of the brain due to air embolism. The patient displayed signs of paralysis on their right side and had difficulty speaking. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the 4fc12 sheath with lot 0010680967 was returned and analyzed. Visual inspection prior to disassembly and functional testing was performed on the shaft, handle, and dilator. No observations were identified during the external visual inspection. Performance testing was then performed with the sentinel blackbelt leak tester. The sheath passed the test as the pressure decay in the device was within an acceptable range. Several flushes and aspirations were performed without issues while a test balloon catheter was inserted. The flush and air aspiration/ingress issue was not reproduced. There was no blockage along the shaft. The shaft and side port were leak-tight and the sheath was able to hold pressure for more than four minutes. In conclusion, the reported air ingress and visible blood were not confirmed through testing. The clinical issues of air embolism, paralysis, st elevation, and impaired speech occurred during and following the procedure. There is no indication of a relation of the adverse event to the performance and malfunction of the product. The sheath passed the returned product inspection as per specification. If information is provided in the future, a supplemental report will be issued.
 
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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 Key12858701
MDR Text Key285498415
Report Number3002648230-2021-00541
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number0010680967
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/22/2021 Patient Sequence Number: 1
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