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

Catalog Number	H1-LS
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the hawkone device was received for evaluation, with the cutter driver inserted in it.).The distal assembly showed a hole to the tecothane layer which ran parallel with the laser drilled coils approximately 2.5cm from the cutter window).The location of the hole was on the same plane as the opening for the cutter window (opposite guidewire tubing).
Event or Problem Description
Physician was using a hawkone device for treatment of a mildly calcified lesion in the left mid superficial femoral artery (sfa).Device was inspected prior to use and prepped as per ifu without issue.Hawkone was put into the patient¿s body once and completed several passes with it.It was reported that when it was taken out for cleaning, there was plaque coming out the side of the (metal) part of the catheter.It was possible to turn off the thumbswitch and the device was safely removed from the patient.On closer inspection, it was observed that there was a hole in that area of the device, and it could not be used a second time.The procedure was successful completed using another ls device.No patient injury reported.
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: 6675908
• Report Number: 2183870-2017-00276
• Device Sequence Number: 11255541
• Product Code: MCW
• UDI-Device Identifier: 00821684057926
• UDI-Public: 00821684057926
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/30/2017

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: 04/10/2019
• Device Catalogue Number: H1-LS
• Device Lot Number: A258602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: 05/30/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1