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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 Death (1802); Hemoptysis (1887); Pneumonia (2011); Respiratory Failure (2484)
Event Date 01/01/2018
Event Type  Death  
Manufacturer Narrative
Concomitant medical product: arctic front advance cardiac cryoablation catheter. Medtronic was made aware of this event through a search of literature publications. It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events. This information is based entirely on journal literature. This event occurred outside the us. All information provided is included in this report. Patient information is limited due to confidentiality concerns. The date of death is not available at the time of this report; as there is no indication of specific lot number/patient information. Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers. The baseline gender/age characteristics is male/75 years old. Without a lot number or device serial number, the manufacturing date cannot be determined. Since no device id was provided, it is unknown if this event has been previously reported. A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Referenced article: ¿efficacy and safety of cryoballoon ablation in the elderly: a multicenter study. ¿ int j cardiol (2018), https://doi. Org/10. 1016/j. Ijcard. 2018. 09. 090. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The literature publication reported the following patient complications during the use of a cryoballoon ablation system: there were two (2) patients who developed cardiac tamponade; which required drainage. There were also eight (8) patients who had phrenic nervepalsy (pnp); all of which resolved within 12 months. There were eight (8) patients who had groin-site complications (bleeding); which required transfusions and/or ¿conservative¿ treatment. There was one (1) patient who experienced a stroke/transient ischemic attack (tia); who recovered without sequelae. There was one (1) patient who experienced pericardial effusion, but no treatment was required. There was one (1) patient who experienced a myocardial infarction/air embolism/st elevation with no effects. There was one (1) patient death. This patient, according to the author, ¿experienced periprocedural haemoptysis, developed pneumonia and died due to nosocomial pneumonia and respiratory failure 13 days following intensive care treatment after ablation. ¿ of note, multiple patients we re noted in the article; however, a one to one correlation could not be made with unique product lot numbers. The status/location of the cryoablation system is unknown. Further follow up did not yet yield any additional information. 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
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key8064037
MDR Text Key126918876
Report Number3002648230-2018-00825
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 11/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4FC12
Device Catalogue Number4FC12
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 11/13/2018 Patient Sequence Number: 1
Treatment
ACHIEVE MAPPING CATHETER
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