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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN SILVERHAWK ATK CATHETER, PERIPHERAL, ATHERECTOMY

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COVIDIEN SILVERHAWK ATK CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Catalog Number P4056
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/19/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the physician intended to use the silverhawk directional atherectomy device to treat a soft tissue lesion, with little tortuosity, no calcification and 99% stenosis in the mid superficial femoral artery(sfa) as per ifu. The device was prepped per ifu with no issues identified. It was reported after two passes the device jammed and became excessively difficult to close. No injury to the patient was reported.
 
Manufacturer Narrative
The thumbswitch stopped functioning in the patient immediately following the second pass. The thumbswitch was successfully turned off but excessive force was required. The cutter was positioned inside the housing and the power was turned off. The device was safely removed from the patient. No deformation was noted in the cutter. A balloon and stent were used to complete the procedure. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSILVERHAWK ATK
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 Key8063633
MDR Text Key127368682
Report Number9612164-2018-03159
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061188
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 12/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/03/2018
Device Catalogue NumberP4056
Device Lot NumberA370139
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 Received12/03/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/03/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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