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

Catalog Number	H1-LS
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cine image analysis summary: the hawkone was not received for evaluation.No ancillary devices from the procedure were received for evaluation.A single cine image was received for evaluation.The single image is of the targeted vessel, the left mid popliteal artery.A guidewire could be seen running the length of artery image.The hawkone 7f directional atherectomy device was not seen in the image.No image of the hawkone 7f directional atherectomy device was provided.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to use a 7f hawkone with a non-medtronic 7fr sheath and a non-medtronic 0.014 guide wire as per the ifu to treat a 60% stenotic lesion in the left mid popliteal artery.The lesion was reported as 80mm in length, plaque and having little calcification.The vessel diameter was reported as 6mm.It was reported that during the procedure the physician encountered difficulty removing the device from the patient and damage was observed to the side of the catheter with plaque build up.The physician was unable to flush the tissue.The procedure was completed using angioplasty.No patient harm was reported.
Additional Manufacturer Narrative
Product analysis: the hawkone was returned for evaluation.It was not connected to a cutter driver.No ancillary devices were included.A visual inspection was completed and a hole to the tecothane was observed approximately 2cm distal of the cutter window.At the location of the hole was the rim of the cutter assembly.The location of the hole was on the top plain of the coiled housing opposite the guidewire tubing.The hole and tecothane material flared outward in a distal direction.The coils showed uneven pacing at the location of the hole showing signs of compression.At the hole the housing was bent at an approximate 45 degree angle.The observed hole is an area where biological debris collected and within the compact stroke (2.2cm distal the cutter window) of the hawkone.Functional testing was not performed due to the risk of likely causing additional damage to the coiled housing where the damage was observed.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: 7620784
• Report Number: 2183870-2018-00339
• Device Sequence Number: 1383643
• Product Code: MCW
• UDI-Device Identifier: 00821684057926
• UDI-Public: 00821684057926
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/16/2018

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: 10/20/2019
• Device Catalogue Number: H1-LS
• Device Lot Number: A363070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 113