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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN (IRVINE) HAWKONE 7F CATHETER, PERIPHERAL, ATHERECTOMY

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COVIDIEN (IRVINE) HAWKONE 7F CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Catalog Number H1-LS
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/14/2017
Event Type  malfunction  
Manufacturer Narrative
Device evaluation summary: the hawkone device with inserted cutter driver was returned for analysis. A specimen cup was also returned with a thin strip of material enclosed. The cutter driver was advanced with the thumb switch in the forward position. The cutter assembly was advanced approximately 2. 9 cm distal the cutter window. The distal assembly was curved upwards at the distal end proximal to the flush mouth. Direct lighting was applied to the distal assembly laser drilled tip, and did not find any damages or evidence of stripping of the inner diameter of the unit. The specimen cup was opened and the strip of material was removed. The material was clear and plastic-like and did not have the physical characteristics of biological matter. The material was approximately 1mm in width and was approximately 7cm in length. The width of the material was constant throughout the material. The material from the specimen cup was consistent with material likely skived/stripped by the cutter blade.
 
Event Description
Physician used a hawkone directional atherectomy device for the treatment of a slightly tortuous, moderately calcified fibrous lesion in the left superficial femoral artery (sfa). Device was inspected before use with no issues noted. Device was prepped without any issue identified. It was reported that after the first insertion, the device was removed and cleaned. During cleaning, the technician noted a string of plastic that flushed out with the tissue. When the operator wished to perform additional atherectomy, another hawkone ls was opened and used. No patient injury reported.
 
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Brand NameHAWKONE 7F
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 Key6712969
MDR Text Key80059500
Report Number2183870-2017-00302
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141801
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2019
Device Catalogue NumberH1-LS
Device Lot NumberA318410
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/28/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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