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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Hemoptysis (1887); ST Segment Elevation (2059); Sepsis (2067); Blood Loss (2597)
Event Date 04/12/2018
Event Type  Injury  
Manufacturer Narrative
Event summary: the patient data files showed eight injections were performed with catheter 2af283 / 6121-82 without any issues or system notices. This is a clinical issue encountered during the procedure. In conclusion, the reported (fever, st-elevation, blood in sputum/hemoptysis, sepsis, bleeding) issues cannot be confirmed through data analysis. This is a clinical issue encountered during the procedure. 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 was observed on the electrocardiogram (ecg). An angiography of the coronary arteries was then performed, and it was decided that the procedure was to be continued. The case was completed with cryo. A day after the case, there was a spike in the patient's temperature, and sepsis was suspected. The patient then had hemoptysis several minutes later. A chest x-ray was subsequently performed, which showed blood in the patient's lungs. A medication was then administered to stabilize the patient. Additionally, a thoracic computed tomography (ct) scan and an operating room transfer was planned. It was noted that the patient lost several pints of blood. No further patient complications have been reported as a result of this event. On (b)(6) 2018: it was further noted that the patient had a competitor transesophageal echocardiogram probe (toe) and a competitor atrial septal defect (asd) closure device placed during the cryo ablation procedure. On (b)(6) 2018: incoming information confirmed that the patient's hospitalization stay was extended. The patient was taken to surgery to identify the source and stop the bleeding.
 
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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
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7496141
MDR Text Key107650986
Report Number3002648230-2018-00300
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUK
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
Report Date 05/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/07/2020
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number14065
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/08/2018
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: 05/08/2018 Patient Sequence Number: 1
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