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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC DXTERITY TRA CATHETER, INTRAVASCULAR, DIAGNOSTIC

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MEDTRONIC, INC DXTERITY TRA CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Catalog Number UNK-CV-DAN-DXT
Device Problems Defective Device (2588); Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A post market clinical follow-up (pmcf) survey was conducted on behalf of medtronic to seek out potential new risks and assess performance of the dxterity diagnostic catheter. Survey results were obtained from an cardiovascular surgeon in practice 20 years. In the past 12 months the physician performed 180 procedures using the dxterity diagnostic catheter. 30 procedures using the 5 fr x 100cm, 120 procedures using the intermediate sizes, and 30 procedures using the 6f x 125cm. The following complications adverse events/effects were reported when using the dxterity diagnostic catheter product over the last 12 months. 2 dissection events occurred which were related to a pre-existing condition or comorbidity. 4 thrombus formation events occurred which were related to a pre-existing condition or comorbidity. 3 embolization events occurred which was related to a pre-existing condition or comorbidity. 6 cardiac arrhythmia events occurred which were related to a pre-existing condition or comorbidity. 2 myocardial infarction events occurred which were related to a pre-existing condition or comorbidity. 4 stroke and transient ischemic attack events occurred which were related to a pre-existing condition or comorbidity. 5 infection events occurred which were related to a pre-existing condition or comorbidity. 10 allergic reaction events occurred which were related to a pre-existing condition or comorbidity. 8 vasospasm events occurred which were related to a pre-existing condition or comorbidity. 4 devices were damaged in the package before use. The events were directly related to the dxterity diagnostic catheter. The events were reported to be due to transport or storage issues. 5 devices were damaged when removed from the package. The events were directly related to the dxterity diagnostic catheter. The events were reported to be due to transport or storage issues. 3 devices had a defective tip. 2 events were related to the procedure but not directly to the dxterity diagnostic catheter. One event was directly related to the dxterity diagnostic catheter. The events were alleged to be due to a defect during manufacturing. For 3 devices, the tip broke off/was damaged. 2 events were related to the procedure but not directly to the dxterity diagnostic catheter. One event was directly related to the dxterity diagnostic catheter. The events were alleged to be due to a defect during manufacturing.
 
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Brand NameDXTERITY TRA
Type of DeviceCATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
MEDTRONIC, INC
37a cherry hill dr
danvers MA 01923
Manufacturer (Section G)
MEDTRONIC, INC
37a cherry hill dr
danvers MA 01923
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key9784531
MDR Text Key182922375
Report Number1220452-2020-00032
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K161287
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK-CV-DAN-DXT
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 Received03/05/2020
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

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