MAUDE Adverse Event Report: COVIDIEN (IRVINE) SILVERHAWK ATK; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	P4052
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician used the silverhawk atk directional atherectomy device to treat a lesion in the superficial femoral artery.It was reported the silverhawk was used to treat an in-stent restenosis (isr), the physician was informed that the silverhawk is contraindicated for isr, but elected to use the device for this procedure.During the procedure the siverhawk became stuck on a stent strut, the rep was called into the room.The silverhawk was turned off; the cutter window was left open.The physician attempted to torque the silverhawk to free the device from the stent strut but was unable to do so.The silverhawk was pulled back and eventually dislodged from the stent cutting through a stent strut as it was being removed from the patient.No patient injury reported.
Additional Manufacturer Narrative
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): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 6641257
• Report Number: 2183870-2017-00260
• Device Sequence Number: 979064
• Product Code: MCW
• UDI-Device Identifier: 00821684074121
• UDI-Public: 00821684074121
• 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
• Report Date (Section B): 05/16/2017

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: 06/01/2018
• Device Model Number: P4052
• Device Lot Number: A286796
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: 05/16/2017
• Initial Report FDA Received Date: 06/14/2017
• Supplement Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 106