MAUDE Adverse Event Report: COVIDIEN HAWKONE 7F; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number	H1-LS
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2018
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
Physician used a hawkone device for the treatment of a 75% stenosed moderately calcified plaque lesion in the distal left superficial femoral artery (sfa).Device was prepped as per ifu without issue.It is reported that a long piece of plaque was noted coming out of the side (mec technology) of the nosecone upon removal of device from sheath prior to cleaning the device.The nosecone appeared to be 3/4 full prior to removing for cleaning so it was not over packed.Physician was concerned that plaque was coming out of the side of nosecone.There were no adverse events or emboli noted distal to treatment area.Procedure completed with this device.
Additional Manufacturer Narrative
The hawkone was received for evaluation.No ancillary devices or cine images from the procedure were received for evaluation.The distal assembly was visually examined and a bulge/eruption of the tecothane coating was noted approximately 20mm from the distal edge of the cutter window.The main body of the bulge runs parallel with the coils of the distal assembly.The mec holes are present along the sides of the distal assembly.Sanguine residue was observed in some of the mec holes within the cutter stroke.There was no apparent yielding or deformation of the distal assembly struts.When examined under higher magnification the ridge of material running longitudinal along the distal assembly appears to have a crystalline structure and when it was touched with a water moistened swab the crystalline material dissolved away.Under the higher magnification and during cleaning of the bulge/eruption it was possible to determine that one of the struts was exposed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HAWKONE 7F
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7341880
• Report Number: 2183870-2018-00152
• Device Sequence Number: 1471021
• Product Code: MCW
• UDI-Device Identifier: 00821684057926
• UDI-Public: 00821684057926
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K141801
• 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): 04/20/2018

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: 12/22/2018
• Device Catalogue Number: H1-LS
• Device Lot Number: A205853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Initial Date Received by Manufacturer: 02/15/2018
• Supplement Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 03/15/2018
• Supplement Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1