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

Catalog Number	H1-LS
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the hawkone device with inserted cutter driver was returned for analysis.A specimen cup was also returned with a thin strip of material enclosed.The cutter driver was advanced with the thumb switch in the forward position.The cutter assembly was advanced approximately 2.9 cm distal the cutter window.The distal assembly was curved upwards at the distal end proximal to the flush mouth.Direct lighting was applied to the distal assembly laser drilled tip, and did not find any damages or evidence of stripping of the inner diameter of the unit.The specimen cup was opened and the strip of material was removed.The material was clear and plastic-like and did not have the physical characteristics of biological matter.The material was approximately 1mm in width and was approximately 7cm in length.The width of the material was constant throughout the material.The material from the specimen cup was consistent with material likely skived/stripped by the cutter blade.
Event or Problem Description
Physician used a hawkone directional atherectomy device for the treatment of a slightly tortuous, moderately calcified fibrous lesion in the left superficial femoral artery (sfa).Device was inspected before use with no issues noted.Device was prepped without any issue identified.It was reported that after the first insertion, the device was removed and cleaned.During cleaning, the technician noted a string of plastic that flushed out with the tissue.When the operator wished to perform additional atherectomy, another hawkone ls was opened and used.No patient injury reported.

• Brand Name: HAWKONE 7F
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 6712969
• Report Number: 2183870-2017-00302
• Device Sequence Number: 1733580
• Product Code: MCW
• UDI-Device Identifier: 00821684057926
• UDI-Public: 00821684057926
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 06/14/2017

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: 07/28/2019
• Device Catalogue Number: H1-LS
• Device Lot Number: A318410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 07/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1