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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND SILVERHAWK ATK CATHETER, PERIPHERAL, ATHERECTOMY

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MEDTRONIC IRELAND SILVERHAWK ATK CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Catalog Number P4055
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician intended to use a second silverhawk to treat a fibrous lesion in the right-mid superficial femoral artery (sfa). The vessel presented little tortuosity and 50% stenosis. The device was inspected prior to use without issues noted. Ifu was followed and the device was prepped without issues identified. It is reported this device was jammed and would not close. The cutter could not be returned to the housing. The device was safely removed from the patient. No visible defects were noted. A third device was used to complete the procedure without further issue. No patient injury reported.
 
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Brand NameSILVERHAWK ATK
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key8128044
MDR Text Key129170808
Report Number9612164-2018-03459
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
Report Date 12/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/07/2020
Device Catalogue NumberP4055
Device Lot Number0009366011
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 Received11/21/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/08/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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