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

Catalog Number	P4056
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The silverhawk was not received for evaluation.No ancillary devices or cine images from the procedure were received.A single photographic image of the device was received.The photographic image shows separation at the distal assembly at the hinge pin, proximal to the cutter window.Due to the clarity and quality of the image it is not possible to determine if the hinge pins remained attached to the distal segment of the distal assembly.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician used a silverhawk device during treatment of a slightly calcified plaque lesion in the left mid-distal superficial femoral artery (sfa).The vessel was described as slightly tortuous.The lesion exhibited 90% stenosis.The device was prepped as per ifu without issue.Following removal of the device and with the thumbswitch in the closed/off position and the cutter was inside of the housing.It was reported that the nosecone of the device appeared to have detached from the shaft and not the guidewire lumen but there is actual separation of the nosecone and shaft of the device.No deformation was reported in the cutter.The lesion was treated with a 5x40 balloon and 6x40 stent.No patient injury reported.

• Brand Name: SILVERHAWK ATK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7365198
• Report Number: 2183870-2018-00178
• Device Sequence Number: 11250298
• Product Code: MCW
• UDI-Device Identifier: 00821684074169
• UDI-Public: 00821684074169
• 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
• Report Date (Section B): 03/23/2018

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: 09/23/2018
• Device Catalogue Number: P4056
• Device Lot Number: A348979
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 03/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 75