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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN HAWKONE 6FR CATHETER, PERIPHERAL, ATHERECTOMY

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COVIDIEN HAWKONE 6FR CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Catalog Number H1-M
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 11/06/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the physician used a hawkone m with a 6f 45cm non-medtronic sheath for treatment of a calcified/plaque lesion in the patients right proximal common iliac artery. The vessel was described as slightly calcified and slightly tortuous. The ifu was followed and the hawkone m was prepped without issue. The vessel was not pre-dilated. It was reported that severe resistance was experienced when attempting to withdraw the device. The wire wrapped around the nosecone of the hawkone m. The nosecone became bent resulting in tip detachment. The tip was reported to have separated at the hinge pin. The guidewire was reported to have been torn from the distal tip. Two cut downs were carried out to remove the detached portion. A non-medtronic stent was placed and the procedure was completed. The patient was reported to be stable.
 
Manufacturer Narrative
Additional information: the nosecone did not completely detach. The two cut downs were performed on both groins to remove the nosecone. The hawkone was not received for evaluation. No ancillary devices from the procedure were received. A single photograph of a cine image was received for evaluation. The cine image shows the cutter housing in the vessel anatomy. The cutter head is not visible in the cutter housing cutter window. The cutter housing does not appear to be separated from the cutter shaft. The cutter housing appears to be separated from the cutter distal assembly coil housing and distal tip. A guidewire appears to run from the cutter housing to the coil housing and distal tip. Based on the cine image the guidewire appears to be prolapsed and the guidewire lumen appears to be zippered. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameHAWKONE 6FR
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
COVIDIEN
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
COVIDIEN
9775 toledo way
irvine CA 92618
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key8128067
MDR Text Key129150032
Report Number2183870-2018-00561
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/29/2020
Device Catalogue NumberH1-M
Device Lot NumberA516437
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 Received12/04/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/30/2017
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: 12/04/2018 Patient Sequence Number: 1
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