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

Catalog Number	P4044
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device analysis: the silverhawk was returned with a cutter driver connected.No ancillary devices were included.The silverhawk was visually inspected.The torque shaft showed a bend approximately 45 degrees beneath the strain relief and the guidewire tubing of the distal assembly was damaged.Under microscopic inspection, a tear was observed at the proximal end of the guidewire tubing and continued distally and stopped at approximately 2cm from the distal tip.The part of the distal end of the guidewire tubing that did not show tearing was bent and buckled.Image analysis: the customer provided an image of a green guidewire where it appeared to be looped back against itself and followed by a "pig-tail" type bend/coil.The image shows areas where the guidewire coating appears sheared off.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use the silverhawk to treat a 20mm plaque lesion with little calcification, and 60% stenosis in the left mid anterior tibial artery.The artery was reported as having little tortuosity and a diameter of 3mm.The device was prepped as per ifu with no issues identified.It was reported a break occurred in the catheter during retraction of the device into the sheath, due to interaction with the guidewire.The procedure was completed using a hawkone-s,.No patient injury was reported.

• Brand Name: SILVERHAWK BTK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7532967
• Report Number: 2183870-2018-00284
• Device Sequence Number: 233388
• Product Code: MCW
• UDI-Device Identifier: 00821684074107
• UDI-Public: 00821684074107
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/22/2018

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: 09/18/2019
• Device Catalogue Number: P4044
• Device Lot Number: A525330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1