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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN IRVINE BTK TURBOHAWK CATHETER, PERIPHERAL, ATHERECTOMY

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COVIDIEN IRVINE BTK TURBOHAWK CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Gangrene (1873)
Event Date 04/01/2018
Event Type  Injury  
Manufacturer Narrative
Event date is literature article published date. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Journal of vascular and interventional radiology this article was written to evaluate the efficacy of peripheral atherectomy device is tasc type c and d femoropopiliteal lesions. The article reports that femoral access was taken and occlusion was crossed using hydrophilic 0. 035¿ guide-wire non-mdt in 8 patients and using 0. 014¿ wire (nitrex, medtronic) in 3 patients. The 0. 035¿ wire was exchanged with 0. 014¿ wire and directional atherectomy device (turbohawk, medtronic) was then used. A distal embolic protection device was not used. Post atherectomy angiogram was taken, followed by dcb angioplasty (medtronic). Digital amputation was reported in 5 patients who had presented with gangrene.
 
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Brand NameBTK TURBOHAWK
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
COVIDIEN IRVINE
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
COVIDIEN IRVINE
9775 toledo way
irvine CA 92618
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key7517796
MDR Text Key108358707
Report Number2183870-2018-00275
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K111723
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 05/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received04/16/2018
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: 05/16/2018 Patient Sequence Number: 1
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