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	11/21/2018
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 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.

• Brand Name: SILVERHAWK ATK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8128044
• Report Number: 9612164-2018-03459
• Device Sequence Number: 1579795
• 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
• Report Date (Section B): 12/04/2018

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: 10/07/2020
• Device Catalogue Number: P4055
• Device Lot Number: 0009366011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1