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

Catalog Number	H1-LX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/07/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Physician attempted to treat patient at the left (proximal, mid and distal) superficial femoral artery using a hawkone directional atherectomy device.Target lesion type was plaque and fibrous.Lesion displayed no tortuosity, little calcification and 100% stenosis.A 7f sheath and 0.014" guidewire were used.Vessel was not pre-dilated.Ifu was followed.It is reported that during use, the nose cone ruptured and plaque was protruding out the side.Procedure was completed using a second device.No patient injury reported.
Additional Manufacturer Narrative
Evaluation summary: the hawkone device was returned for evaluation.The device was inspected and noted a tear to the tecothane of the laser drilled tip approximately 2 cm distal the cutter window.The hole was noted on the same plane as the cutter window opening (opposite plane of guidewire tubing).The cutter assembly was advanced approximately 2.8 cm distal the cutter window.Under microscope, tissue was noted protruding out between the laser drilled coils at the location of the tear/hole.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: HAWKONE 7F
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 6549701
• Report Number: 2183870-2017-00201
• Device Sequence Number: 1010203
• Product Code: MCW
• UDI-Device Identifier: 00821684057933
• UDI-Public: 00821684057933
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,consum
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2017

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: 05/07/2019
• Device Catalogue Number: H1-LX
• Device Lot Number: A274000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Initial Date Received by Manufacturer: 04/07/2017
• Supplement Date Received by Manufacturer: 06/13/2017; 06/13/2017
• Initial Report FDA Received Date: 05/05/2017
• Supplement Report FDA Received Date: 07/12/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 87