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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 Gas Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Air Embolism (1697); Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059); Exit Block (2628); No Code Available (3191)
Event Date 12/09/2019
Event Type  Injury  
Manufacturer Narrative
The data files were returned and analyzed. The data files showed that at least eight applications were performed with balloon catheter afapro28 with lot number 98927 without any issue on the date of the event. In conclusion, the air ingress and clinical issues which were encountered during the procedure which could not be assessed via data analysis. The analysis of the physical product is pending. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a cryo ablation procedure, st elevation and hypotension were observed. The procedure was paused and an angiography was performed, where a coronary spasm was observed in the right coronary artery (rca). Medications were administered when atrioventricular (av) block was temporarily developed. Air was then observed in the aorta and was aspirated. The st elevation resolved, but the rca spasm remained. Further medications were administered and the procedure began again. The st elevation returned and resolved by air aspiration and medications. The case was completed with cryo. No further patient complications have been reported as a result of this event.
 
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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 Key9540546
MDR Text Key185359784
Report Number3002648230-2020-00003
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/23/2021
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number0009925327
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2019
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: 01/02/2020 Patient Sequence Number: 1
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