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	03/19/2019
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 using a silverhawk to treat a moderately calcified plaque cto in the right proximal/mid/distal superficial femoral artery (sfa).Moderate tortuosity was reported.A non medtronic 7fr 45cm sheath and a non medtronic 0.035 180cm stiff guidewire were used in the procedure.The ifu was followed.After the first pass the device was removed from the patient.The thumbswitch would not advance forward and the device would no longer pack.A new silverhawk device and driver were used to complete the procedure with a good result.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation: the device was removed from the packaging.Examination of the device revealed a flattened section of the distal assembly.The flattened section was approximately 0.7cm distal to the cutter window and continued approximately to 1.8cm.Biological debris was noted within the housing; no holes or biological debris were identified protruding from the tecothane coating.Examination of the cutter window revealed the cutter was within the window and the distal end of the cutter window was torn laterally.The cutter was attempted to be advanced; however, it was unable to advance.The silverhawk was connected to the cutter driver and retracted while activated.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.Damage was noted to the distal edge of the cutter where it made contact with the cutter window.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the thumbswitch could be turned off.The cutter was inside the housing and the device was safely removed from the patient.No deformation was noted in the cutter.No pieces of the cutter noticed to be missing.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: 8451092
• Report Number: 9612164-2019-01035
• Device Sequence Number: 240660
• Product Code: MCW
• UDI-Device Identifier: 00643169968431
• UDI-Public: 00643169968431
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/17/2019

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: 11/18/2020
• Device Catalogue Number: P4055
• Device Lot Number: 0009447826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 03/26/2019; 06/11/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 04/11/2019; 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR