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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP UNKNOWN CATHETER, STEERABLE

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MEDTRONIC CRYOCATH LP UNKNOWN CATHETER, STEERABLE Back to Search Results
Model Number CRYO-UNKNOWN
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Vascular System (Circulation), Impaired (2572)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
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. All information provided is included in this report. Patient information is limited due to confidentiality concerns. The baseline gender/age of the patients represented in the article is male/61 years old. 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 model listed in the report is a representative of the model family, as there is no specific model listed. 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. Referenced article: ¿second-generation cryoballoon ablation as a first-line treatment of symptomatic atrial fibrillation: two-year outcome and predictors of recurrence after a single procedure. ¿ international journal of cardiology 259 (2018) 76¿81. Https://doi. Org/10. 1016/j. Ijcard. 2017. 11. 011. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The literature publication reports the following patient complications while using a cryoablation balloon system: there were 16 patients who experienced phrenic nerve palsy (pnp); all of which recovered during the six-month follow up period. There were seven (7) patients who experienced groin hematomas which were treated ¿conservatively. ¿ one (1) patient had pericardial effusion, but it did not require any treatment. Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique device lot numbers. The status/location of the cryoballoon 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 NameUNKNOWN
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 Key7434761
MDR Text Key105629861
Report Number3002648230-2018-00229
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
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 04/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCRYO-UNKNOWN
Device Catalogue NumberCRYO-UNKNOWN
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 Received04/03/2018
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

Patient Treatment Data
Date Received: 04/16/2018 Patient Sequence Number: 1
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