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

Model Number	P4055
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the silverhawk was returned with the laser drilled tip fractured and separated.The distal segment of the fractured component was not returned.The separation took place at approximately 1.8cm distal the cutter window.The laser drilled tip which remained showed signs of twisting.The guidewire tubing was intact.A 0.014" guidewire from the lab was loaded into the guidewire tubing.
Event or Problem Description
Physician was using a silverhawk device for an atherectomy procedure of a fibrous lesion in the left proximal sfa with 80% stenosis.The device was prepped per ifu.It was reported there was difficulty in flushing the tissue out of the nosecone.Probe was unable to push out the tissue.The procedure was completed using a new turbohawk device.No injury to the patient was reported.
Additional Manufacturer Narrative
Additional info received on july 31, 2017: the fracture in the nosecone occurred during the cleaning process, when the physician/technician were looking for tissue in the nosecone.The cut/fracture was caused deliberately by the physician during flushing outside of the body.No pieces of device were reported to be left in the body.If information is provided in the future, a supplemental report will be issued.
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; 9775 toledo way; irvine CA 92618
• MDR Report Key: 6676027
• Report Number: 2183870-2017-00277
• Device Sequence Number: 46039
• Product Code: MCW
• UDI-Device Identifier: 00821684074145
• UDI-Public: 00821684074145
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2017

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: 05/14/2018
• Device Model Number: P4055
• Device Catalogue Number: P4055
• Device Lot Number: A277692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2017
• Initial Date Received by Manufacturer: 05/31/2017
• Supplement Date Received by Manufacturer: 05/31/2017; 05/31/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 07/31/2017; 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: 79 YR
• Patient Weight: 72