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

Catalog Number	P4055
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use a silverhawk device.The device was inspected and prepped as per ifu with no issues.It was reported that after multiple passes through a moderately calcified lesion with 50% stenosis at the mid right superficial femoral artery (sfa) the thumb switch would not advance to close the blade.No patient injury was reported.
Additional Manufacturer Narrative
A 7frx45cm non medtronic sheath and a 300cm nitrex guidewire were used in the procedure.No resistance was encountered advancing or removing the device.There were issues packing the nose cone during the procedure but the distal tip was not deformed or damaged.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation: returned contents: silverhawk was returned with a detached cutter driver.No other ancillary devices were included.Visual inspection: the silverhawk was removed from the packaging and inspected.It was observed the cutter was located within the cutter window.It was noted the distal rim of the cutter window was tore laterally.Biological debris was observed behind the cutter and within the housing assembly inner diameter.Functional testing: the silverhawk was connected to the cutter driver and retracted.The thumb switch was then pushed forward; but encountered resistance.It was observed the cutter remained in the cutter window with the cutter crashing against the distal rim of the cutter window.With the cutter pulled back, the distal rim of the cutter window was inspected under microscope.It was noted the rim was intact but bent inwards at the area of the observed tear to the platinum iridium.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SILVERHAWK ATK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8264020
• Report Number: 9612164-2019-00254
• Device Sequence Number: 2100203
• Product Code: MCW
• UDI-Device Identifier: 00643169968431
• UDI-Public: 00643169968431
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/14/2020
• Device Catalogue Number: P4055
• Device Lot Number: 0009442231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 01/21/2019; 04/05/2019
• Initial Report FDA Received Date: 01/21/2019
• Supplement Report FDA Received Date: 02/13/2019; 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1