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

Catalog Number	H1-LS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hawkone was returned connected to a cutter driver.A spider fx was loaded within the distal rotating tip of the catheter and a torqueing device was loosely attached to the capture wire of the spider fx.Visual inspection and inspection of the device under a microscope was performed.The distal tip of the hawkone showed the spider capture wire loaded at the tip.The torque shaft of the hawkone beneath the strain relief was bent at an approximate 90 degree angle.It was observed the proximal portion of the hawkone guidewire lumen was protruding up and was detached from the distal assembly housing.A space on device where the proximal end of the guidewire tubing had been attached was observed.The detached proximal end of the guidewire tubing was located at a bend of the spider capture wire.No tearing of the guidewire lumen was noted but zipper tearing throughout the guidewire tubing was observed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use the hawkone with a spider fx to treat a cto, with moderate plaque, soft tissue calcification, with little tortuosity in the right proximal popliteal artery as per ifu.There were no abnormalities in relation to anatomy.Artery length was 5.5mm, lesion length was 150mm.It was reported the hawkone was removed from the patient over the guidewire, to clean the device with no issues noted.The physician encountered difficulty reinserting the device back into the patient, whilst advancing the device, the device became stuck in the 7fr non medtronic sheath and the wire appeared to be coming out of the wire lumen early.The hawkone and spider fx were removed from the patient as a unit.The turbohawk lx was used to complete the procedure.No patient symptoms, complications or patient injury was reported.

• Brand Name: HAWKONE 7F
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7457882
• Report Number: 9612164-2018-00872
• Device Sequence Number: 1540307
• Product Code: MCW
• UDI-Device Identifier: 00821684057926
• UDI-Public: 00821684057926
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 04/25/2018

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: 11/29/2019
• Device Catalogue Number: H1-LS
• Device Lot Number: A382073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1